Validations Queue

47,884 candidate doc → node links pending adjudication. Each was auto-generated by cosine similarity ≥ 0.55 between document and prediction embeddings (bge-base-en-v1.5, 768-dim). Showing page 1 of 5, 500 rows by similarity. Adjudicating updates doc_node_links.reviewed=true with the chosen polarity, writes per-link rows to audit_log, and removes the row from this queue. Phase 4 inference will use confirmed corroborates/contradicts links as Bayesian evidence.

Pending (total)
47,884
Reviewed
13
Filtered
2,297
page 1 / 5
Showing on page
500

Filters

URL params control source + min-similarity threshold
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Bulk auto-confirm by similarity threshold

Confirm or label (corroborates / contradicts) all unreviewed links above a similarity threshold in one transaction. Each affected row writes a per-link audit_log entry. Capped at 1,000 links per call. Use Preview first.

Source0 selected · 0 visible
Bulk action
SimDocSourcePredDomainPrior
0.71
FDA ANDA212336: ANDA212336 ((unspecified)) — DR REDDYS LABS LTD
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.70
FDA ANDA214618: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.70
FDA ANDA211182: ANDA211182 ((unspecified)) — HETERO LABS LTD V
fda
2026-04-16
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA NDA220442: NDA220442 ((unspecified)) — SHIONOGI INC
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA213093: ANDA213093 ((unspecified)) — QILU PHARM CO LTD
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA201452: LENALIDOMIDE (LENALIDOMIDE) — ARROW INTL
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA216213: LENALIDOMIDE (LENALIDOMIDE) — AMNEAL
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA NDA218197: TRUQAP (CAPIVASERTIB) — ASTRAZENECA
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA NDA217180: JAKAFI XR (RUXOLITINIB PHOSPHATE) — INCYTE CORPORATION
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA NDA020515: ZOLADEX (GOSERELIN) — TERSERA
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA210236: POMALIDOMIDE (POMALIDOMIDE) — HETERO LABS LTD V
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA220499: ANDA220499 ((unspecified)) — ALEMBIC PHARMACEUTICALS LIMITED
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA212414: LENALIDOMIDE (LENALIDOMIDE) — HETERO LABS LTD V
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA208539: TICAGRELOR (TICAGRELOR) — MICRO LABS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA210480: LENALIDOMIDE (LENALIDOMIDE) — ALVOGEN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA220421: ANDA220421 ((unspecified)) — HETERO LABS LIMITED, VEMAGAL
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA217265: LENALIDOMIDE (LENALIDOMIDE) — QILU
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA203364: MESNA (MESNA) — RISING
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA NDA214120: ONUREG (AZACITIDINE) — BRISTOL
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA219346: ANDA219346 ((unspecified)) — SANDOZ INC
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA217281: LENALIDOMIDE (LENALIDOMIDE) — NOVUGEN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA NDA217379: NDA217379 ((unspecified)) — FLEX PHARMA, LLC
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA BLA761070: FASENRA (BENRALIZUMAB) — ASTRAZENECA AB
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA NDA212576: INQOVI (CEDAZURIDINE) — TAIHO ONCOLOGY
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA220143: ANDA220143 ((unspecified)) — HETERO LABS LIMITED
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA209348: LENALIDOMIDE (LENALIDOMIDE) — DR REDDYS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA NDA019726: ZOLADEX (GOSERELIN ACETATE) — TERSERA
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA212975: IMATINIB MESYLATE (IMATINIB MESYLATE) — HETERO LABS LTD V
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA220104: MIRTAZAPINE (MIRTAZAPINE) — MICRO LABS
fda
2026-05-19
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA NDA216403: FILSPARI (SPARSENTAN) — TRAVERE
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA220221: VERICIGUAT (VERICIGUAT) — TORRENT PHARMACEUTICALS LTD
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA BLA761055: DUPIXENT (DUPILUMAB) — REGENERON PHARMACEUTICALS
fda
2026-04-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA079162: TOPIRAMATE (TOPIRAMATE) — INVAGEN PHARMS
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA207110: BOSENTAN (BOSENTAN) — WATSON LABS INC
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA207223: DIACOMIT (STIRIPENTOL) — BIOCODEX SA
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA205254: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — MYLAN LABS LTD
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA215356: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — AUROBINDO PHARMA LTD
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA210655: PERSERIS KIT (RISPERIDONE) — INDIVIOR
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA090263: LEVETIRACETAM (LEVETIRACETAM) — CHARTWELL MOLECULAR
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA213405: LENALIDOMIDE (LENALIDOMIDE) — TORRENT
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA218316: WEGOVY (SEMAGLUTIDE) — NOVO
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA BLA761328: BEYFORTUS (NIRSEVIMAB-ALIP) — ASTRAZENECA AB
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA073484: VALPROIC ACID (VALPROIC ACID) — BIONPHARMA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA216068: ENZALUTAMIDE (ENZALUTAMIDE) — SANDOZ
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA213165: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA214398: LENALIDOMIDE (LENALIDOMIDE) — LUPIN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA211545: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — ALKEM LABS LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA213912: LENALIDOMIDE (LENALIDOMIDE) — MYLAN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA090508: FINASTERIDE (FINASTERIDE) — SUN PHARM
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA204345: CAPECITABINE (CAPECITABINE) — DR REDDYS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA218488: EVEROLIMUS (EVEROLIMUS) — APOTEX
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA215243: RAMELTEON (RAMELTEON) — MICRO LABS
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA BLA761451: SAPHNELO (ANIFROLIMAB-FNIA) — ASTRAZENECA AB
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA020578: ZOLADEX (GOSERELIN ACETATE) — TERSERA
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA211026: MACITENTAN (MACITENTAN) — SEASONS BIOTECH
fda
2026-05-19
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA220264: VERICIGUAT (VERICIGUAT) — CHANGZHOU PHARMACEUTICAL FACTORY
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA211506: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — MACLEODS PHARMS LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA022433: BRILINTA (TICAGRELOR) — ASTRAZENECA
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA078582: LEVETIRACETAM (LEVETIRACETAM) — STRIDES PHARMA
fda
2026-04-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA204741: CAPECITABINE (CAPECITABINE) — AMNEAL PHARMS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA219189: GALLIUM GA-68 GOZETOTIDE (GALLIUM GA-68 GOZETOTIDE) — IONETIX
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA220482: NDA220482 ((unspecified)) — HAISCO PHARMACEUTICAL GROUP CO LTD
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA206709: DIACOMIT (STIRIPENTOL) — BIOCODEX SA
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA215336: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — AMNEAL
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA219249: ITOVEBI (INAVOLISIB) — GENENTECH INC
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA207760: BOSENTAN (BOSENTAN) — ZYDUS PHARMS
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA217554: LENALIDOMIDE (LENALIDOMIDE) — DEVA HOLDING AS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA211523: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — AIZANT
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA211182: ANDA211182 ((unspecified)) — HETERO LABS LTD V
fda
2026-04-16
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.67
FDA BLA761069: IMFINZI (DURVALUMAB) — ASTRAZENECA UK LTD
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA219257: ANDA219257 ((unspecified)) — RENATA LIMITED
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA219293: DANZITEN (NILOTINIB TARTRATE) — AZURITY
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA204026: POMALYST (POMALIDOMIDE) — BRISTOL
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA220137: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SOMERSET THERAPS LLC
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA211560: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — ALEMBIC
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA217239: TORSEMIDE (TORSEMIDE) — MICRO LABS
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA BLA761100: ONTRUZANT (TRASTUZUMAB-DTTB) — SAMSUNG BIOEPIS CO LTD
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA BLA761352: BIZENGRI (ZENOCUTUZUMAB-ZBCO) — MERUS N.V.
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA220274: SODIUM ACETATE (SODIUM ACETATE) — EXTROVIS
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA217477: ANDA217477 ((unspecified)) — HAINAN POLY PHARM. CO., LTD.
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA215260: SUGAMMADEX (SUGAMMADEX) — TAMARANG SA
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA211022: LENALIDOMIDE (LENALIDOMIDE) — APOTEX
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA200217: LORAZEPAM (LORAZEPAM) — RISING
fda
2026-05-04
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA211255: LINACLOTIDE (LINACLOTIDE) — ACTAVIS LABS FL INC
fda
2026-05-19
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA220465: ANDA220465 ((unspecified)) — SANDOZ INC
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA090517: VALPROIC ACID (VALPROIC ACID) — QUAGEN
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA211846: LENALIDOMIDE (LENALIDOMIDE) — SUN PHARM
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA BLA761111: NYVEPRIA (PEGFILGRASTIM-APGF) — HOSPIRA INC
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA213756: KOSELUGO (SELUMETINIB SULFATE) — ASTRAZENECA
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA081099: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — BARR
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA212927: TIOCYSTIN (TIOPRONIN) — CASPER PHARMA LLC
fda
2026-06-02
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA213405: LENALIDOMIDE (LENALIDOMIDE) — TORRENT
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.66
FDA ANDA210164: POMALIDOMIDE (POMALIDOMIDE) — APOTEX
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA212306: XPOVIO (SELINEXOR) — KARYOPHARM THERAPS
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA220444: PALBOCICLIB (PALBOCICLIB) — DR. REDDY'S LABORATORIES LIMITED
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA BLA125514: KEYTRUDA (PEMBROLIZUMAB) — MERCK SHARP DOHME
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA211156: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — INVENTIA
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA216993: VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — DAIICHI SANKYO INC
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA220328: FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) — APPCO
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA019414: CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) — BRACCO
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA218662: UBROGEPANT (UBROGEPANT) — ZYDUS PHARMACEUTICALS (USA) INC.
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA091404: MEROPENEM (MEROPENEM) — ACS DOBFAR
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA215356: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — AUROBINDO PHARMA LTD
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.66
FDA ANDA212414: LENALIDOMIDE (LENALIDOMIDE) — HETERO LABS LTD V
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.66
FDA NDA215833: PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — NOVARTIS
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA209224: LACOSAMIDE (LACOSAMIDE) — AUROBINDO PHARMA LTD
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA BLA761106: HERCEPTIN HYLECTA (TRASTUZUMAB AND HYALURONIDASE-OYSK) — GENENTECH INC
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA211531: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — LUPIN
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA210435: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA200542: LORAZEPAM (LORAZEPAM) — RISING
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA220041: TOPIRAMATE (TOPIRAMATE) — RICONPHARMA LLC
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA213829: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — SOMERSET THERAPS LLC
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA220837: EVDI (TRABECTEDIN) — APOTEX
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA217957: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — UBI
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA202420: CALCIUM ACETATE (CALCIUM ACETATE) — CHARTWELL MOLECULAR
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA071198: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — BARR
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA021732: VANTAS (HISTRELIN ACETATE) — ENDO OPERATIONS
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA220055: ANDA220055 ((unspecified)) — MSN LABORATORIES PRIVATE LIMITED
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA ANDA210154: LENALIDOMIDE (LENALIDOMIDE) — ZYDUS PHARMS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.66
FDA NDA203049: ARGATROBAN (ARGATROBAN) — HIKMA PHARM CO LTD
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761349: COSENTYX (SECUKINUMAB) — NOVARTIS PHARMS CORP
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761183: TZIELD (TEPLIZUMAB-MZWV) — PROVENTION BIO INC
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220437: TIVOZANIB (TIVOZANIB) — SANDOZ INC
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA071199: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — BARR
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA212336: ANDA212336 ((unspecified)) — DR REDDYS LABS LTD
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA NDA022561: MAVENCLAD (CLADRIBINE) — EMD SERONO INC
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215332: OXCARBAZEPINE (OXCARBAZEPINE) — AUCTA
fda
2026-06-02
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215575: ANDA215575 ((unspecified)) — QILU PHARM HAINAN
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA210386: CANAGLIFLOZIN (CANAGLIFLOZIN) — AUROBINDO PHARMA LTD
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA020941: ABREVA (DOCOSANOL) — HALEON US HOLDINGS
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA215256: WEGOVY (SEMAGLUTIDE) — NOVO
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220137: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SOMERSET THERAPS LLC
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA BLA761309: COLUMVI (GLOFITAMAB-GXBM) — GENENTECH INC
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA213885: LENALIDOMIDE (LENALIDOMIDE) — EUGIA PHARMA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219271: CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) — HETERO LABS LIMITED
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA213267: THALIDOMIDE (THALIDOMIDE) — NATCO
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA091541: LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) — MICRO LABS
fda
2026-04-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA213929: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — LEADING
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA021488: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761032: SILIQ (BRODALUMAB) — VALEANT LUXEMBOURG
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761304: VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — ARGENX BV
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761381: OPDIVO QVANTIG (NIVOLUMAB) — BRISTOL-MYERS SQUIBB
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA200880: ACETAZOLAMIDE SODIUM (ACETAZOLAMIDE SODIUM) — MYLAN ASI
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA217497: TRETINOIN (TRETINOIN) — AMNEAL
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA077420: LAMOTRIGINE (LAMOTRIGINE) — RISING
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220043: VORICONAZOLE (VORICONAZOLE) — HAINAN POLY PHARM
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211312: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — SANDOZ
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA209956: POMALIDOMIDE (POMALIDOMIDE) — TEVA PHARMS USA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220326: VILOXAZINE HYDROCHLORIDE (VILOXAZINE HYDROCHLORIDE) — APPCO PHARMA LLC
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761468: HEPCLUDEX (BULEVIRTIDE-GMOD) — GILEAD SCIENCES INC
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA219943: KOSELUGO (SELUMETINIB) — ASTRAZENECA
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA208400: XATMEP (METHOTREXATE SODIUM) — AZURITY
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA210275: POMALIDOMIDE (POMALIDOMIDE) — MYLAN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA205035: TRANEXAMIC ACID (TRANEXAMIC ACID) — EUGIA PHARMA
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA071130: HALOPERIDOL (HALOPERIDOL) — AIPING PHARM INC
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211533: DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (DAPAGLIFLOZIN) — MSN
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211563: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — ALKEM LABS LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA214216: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (EMTRICITABINE) — MACLEODS PHARMS LTD
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA205402: PALIPERIDONE (PALIPERIDONE) — I3 PHARMS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA207740: OMEPRAZOLE (OMEPRAZOLE) — DR REDDYS
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211135: RIOCIGUAT (RIOCIGUAT) — MSN
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA210215: AMANTADINE HYDROCHLORIDE (AMANTADINE HYDROCHLORIDE) — POM PHARMA
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA202811: LINZESS (LINACLOTIDE) — ABBVIE
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA018900: METRO I.V. IN PLASTIC CONTAINER (METRONIDAZOLE) — B BRAUN
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA214956: GABAPENTIN (GABAPENTIN) — ASCENT PHARMS INC
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA021880: REVLIMID (LENALIDOMIDE) — BRISTOL MYERS SQUIBB
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA ANDA219540: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — MSN
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA072736: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA075471: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — MEITHEAL
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA218691: CEFIXIME (CEFIXIME) — FDC LTD
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219869: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — HETERO LABS LTD V
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA214056: ONAPGO (APOMORPHINE HYDROCHLORIDE) — MDD US
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA090170: LAMOTRIGINE (LAMOTRIGINE) — UNICHEM LABS LTD
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA072733: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA204345: CAPECITABINE (CAPECITABINE) — DR REDDYS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA BLA761195: VYVGART (EFGARTIGIMOD ALFA) — ARGENX BV
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA217265: LENALIDOMIDE (LENALIDOMIDE) — QILU
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA ANDA209348: LENALIDOMIDE (LENALIDOMIDE) — DR REDDYS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA ANDA206371: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — MICRO LABS
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215759: LENALIDOMIDE (LENALIDOMIDE) — BIOCON PHARMA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA207974: FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD HYDROCHLORIDE) — ALEMBIC
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA103792: HERCEPTIN (TRASTUZUMAB) — GENENTECH
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA216453: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ELITE LABS INC
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA207037: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — ALKEM LABS LTD
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA212773: IMATINIB MESYLATE (IMATINIB MESYLATE) — EUGIA PHARMA
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219408: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — SCIEGEN PHARMACEUTICALS INC
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA218897: VALSARTAN (VALSARTAN) — LAURUS
fda
2026-04-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215759: LENALIDOMIDE (LENALIDOMIDE) — BIOCON PHARMA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA ANDA208055: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — TORRENT
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA063065: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA217432: FAMOTIDINE (FAMOTIDINE) — LUPIN
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA218197: TRUQAP (CAPIVASERTIB) — ASTRAZENECA
fda
2026-05-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA NDA212102: FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — UCB INC
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211747: OXCARBAZEPINE (OXCARBAZEPINE) — ZYDUS
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.65
FDA NDA202293: FARXIGA (DAPAGLIFLOZIN) — ASTRAZENECA AB
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA208539: TICAGRELOR (TICAGRELOR) — MICRO LABS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA218441: SITAGLIPTIN (SITAGLIPTIN) — BIOCON PHARMA LTD
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA209500: CAPLYTA (LUMATEPERONE TOSYLATE) — INTRA-CELLULAR
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA214618: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA215826: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — ZYDUS PHARMS
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA218488: EVEROLIMUS (EVEROLIMUS) — APOTEX
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA207947: UPTRAVI (SELEXIPAG) — ACTELION
fda
2026-05-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220104: MIRTAZAPINE (MIRTAZAPINE) — MICRO LABS
fda
2026-05-19
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA018569: FUROSEMIDE (FUROSEMIDE) — EPIC PHARMA LLC
fda
2026-06-02
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA211535: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — CIPLA
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219593: PREGABALIN (PREGABALIN) — UNICHEM
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA212963: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — EUGIA PHARMA
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA214376: MYCOPHENOLATE SODIUM (MYCOPHENOLATE SODIUM) — YICHANG HUMANWELL
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA213603: GABAPENTIN (GABAPENTIN) — ZHEJIANG YONGTAI
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA201446: FALLBACK SOLO (LEVONORGESTREL) — LUPIN
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA021343: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA021379: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA204741: CAPECITABINE (CAPECITABINE) — AMNEAL PHARMS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA079204: LAMOTRIGINE (LAMOTRIGINE) — TARO
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA214275: UPTRAVI (SELEXIPAG) — ACTELION
fda
2026-05-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA217552: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ALEMBIC
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA761139: ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — DAIICHI SANKYO
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA076781: ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) — HIKMA FARMACEUTICA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA213165: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA BLA125504: COSENTYX (SECUKINUMAB) — NOVARTIS PHARMS CORP
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA211482: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — AJANTA PHARMA LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA125554: OPDIVO (NIVOLUMAB) — BRISTOL MYERS SQUIBB
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA209125: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — EUGIA PHARMA
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA213362: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — DAITO
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA125166: SOLIRIS (ECULIZUMAB) — ALEXION PHARM
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA021366: CRESTOR (ROSUVASTATIN CALCIUM) — ASTRAZENECA
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA125261: STELARA (USTEKINUMAB) — CENTOCOR ORTHO BIOTECH INC
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA207110: BOSENTAN (BOSENTAN) — WATSON LABS INC
fda
2026-04-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA213912: LENALIDOMIDE (LENALIDOMIDE) — MYLAN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA021731: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210689: FOSAPREPITANT DIMEGLUMINE (FOSAPREPITANT DIMEGLUMINE) — LUPIN
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA078480: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — APOTEX
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA217186: CREXONT (CARBIDOPA) — IMPAX
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219072: CARBAMAZEPINE (CARBAMAZEPINE) — YICHANG HUMANWELL
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA216992: DEFLAZACORT (DEFLAZACORT) — UPSHER SMITH LABS
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA218872: LENALIDOMIDE (LENALIDOMIDE) — ACCORD HLTHCARE
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA202667: COSOPT PF (DORZOLAMIDE HYDROCHLORIDE) — THEA PHARMA
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA072734: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA205422: REXULTI (BREXPIPRAZOLE) — OTSUKA
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA215276: NICOTINE POLACRILEX (NICOTINE POLACRILEX) — DR REDDYS LABS SA
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA208573: VENCLEXTA (VENETOCLAX) — ABBVIE
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA040054: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — HIKMA
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219319: GABAPENTIN (GABAPENTIN) — SENORES PHARMS
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA077420: LAMOTRIGINE (LAMOTRIGINE) — RISING
fda
2026-05-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA081235: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — MYLAN
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA218405: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — MANKIND PHARMA LTD
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA220442: NDA220442 ((unspecified)) — SHIONOGI INC
fda
2026-05-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA210249: POMALIDOMIDE (POMALIDOMIDE) — EUGIA PHARMA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA210655: PERSERIS KIT (RISPERIDONE) — INDIVIOR
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA214957: GABAPENTIN (GABAPENTIN) — ASCENT PHARMS INC
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220660: ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE) — AIZANT
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA215430: AUVELITY (BUPROPION HYDROCHLORIDE) — AXSOME
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA019010: LUPRON (LEUPROLIDE ACETATE) — ABBVIE ENDOCRINE INC
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA076958: LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) — TEVA
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220717: ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) — UMEDICA LABS PVT
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA212576: INQOVI (CEDAZURIDINE) — TAIHO ONCOLOGY
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA217281: LENALIDOMIDE (LENALIDOMIDE) — NOVUGEN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA213093: ANDA213093 ((unspecified)) — QILU PHARM CO LTD
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA BLA761235: VABYSMO (FARICIMAB-SVOA) — GENENTECH INC
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA205756: METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) — RISING
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA217180: JAKAFI XR (RUXOLITINIB PHOSPHATE) — INCYTE CORPORATION
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA020785: THALOMID (THALIDOMIDE) — BRISTOL-MYERS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210236: POMALIDOMIDE (POMALIDOMIDE) — HETERO LABS LTD V
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA BLA761034: TECENTRIQ (ATEZOLIZUMAB) — GENENTECH INC
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA212371: EMPAGLIFLOZIN (EMPAGLIFLOZIN) — AUROBINDO PHARMA LIMITED
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220366: LACOSAMIDE (LACOSAMIDE) — STERANCO HLTHCARE
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA207717: OXCARBAZEPINE (OXCARBAZEPINE) — RUBICON RESEARCH
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA209091: QTERN (DAPAGLIFLOZIN) — ASTRAZENECA AB
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA211022: LENALIDOMIDE (LENALIDOMIDE) — APOTEX
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA BLA125409: PERJETA (PERTUZUMAB) — GENENTECH
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA206863: DALFAMPRIDINE (DALFAMPRIDINE) — ACCORD HLTHCARE
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA091655: ESCITALOPRAM OXALATE (ESCITALOPRAM OXALATE) — MICRO LABS
fda
2026-04-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA761068: CRYSVITA (BUROSUMAB-TWZA) — KYOWA KIRIN
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219473: CENOBAMATE (CENOBAMATE) — AUROBINDO PHARMA LIMITED
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA020515: ZOLADEX (GOSERELIN) — TERSERA
fda
2026-05-06
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA210308: YONSA (ABIRATERONE ACETATE) — SUN PHARM
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210040: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — AMNEAL PHARMS
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA761354: TOFIDENCE (TOCILIZUMAB-BAVI) — BIOGEN MA
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA201749: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — SUN PHARM
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA022180: FERAHEME (FERUMOXYTOL) — AZURITY
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA022472: AFREZZA (INSULIN RECOMBINANT HUMAN) — MANNKIND
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA079099: LAMOTRIGINE (LAMOTRIGINE) — GLENMARK PHARMS LTD
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA206252: QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) — ACCORD HLTHCARE
fda
2026-04-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220147: TOLVAPTAN (TOLVAPTAN) — ALKEM LABS LTD
fda
2026-04-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210480: LENALIDOMIDE (LENALIDOMIDE) — ALVOGEN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA210154: LENALIDOMIDE (LENALIDOMIDE) — ZYDUS PHARMS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA220078: VORICONAZOLE (VORICONAZOLE) — ZHEJIANG NOVUS
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA208283: EPLERENONE (EPLERENONE) — BRECKENRIDGE
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA217379: NDA217379 ((unspecified)) — FLEX PHARMA, LLC
fda
2026-05-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA215332: OXCARBAZEPINE (OXCARBAZEPINE) — AUCTA
fda
2026-06-02
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA071130: HALOPERIDOL (HALOPERIDOL) — AIPING PHARM INC
fda
2026-04-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA ANDA072735: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA079204: LAMOTRIGINE (LAMOTRIGINE) — TARO
fda
2026-05-06
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA204114: MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — NOVARTIS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA208433: LINAGLIPTIN (LINAGLIPTIN) — TEVA PHARMS USA
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA220482: NDA220482 ((unspecified)) — HAISCO PHARMACEUTICAL GROUP CO LTD
fda
2026-05-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.64
FDA NDA201848: HEPZATO (MELPHALAN HYDROCHLORIDE) — DELCATH SYSTEMS INC
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA090170: LAMOTRIGINE (LAMOTRIGINE) — UNICHEM LABS LTD
fda
2026-04-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA218509: IVERMECTIN (IVERMECTIN) — AJANTA PHARMA LTD
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA200217: LORAZEPAM (LORAZEPAM) — RISING
fda
2026-05-04
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA218558: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — MICRO LABS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA078625: LAMOTRIGINE (LAMOTRIGINE) — RUBICON RESEARCH
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA219878: BAXFENDY (BAXDROSTAT) — ASTRAZENECA AB
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA214733: VENETOCLAX (VENETOCLAX) — DR REDDYS
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA208028: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — INVAGEN PHARMS
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA207717: OXCARBAZEPINE (OXCARBAZEPINE) — RUBICON RESEARCH
fda
2026-05-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA NDA214018: NULIBRY (FOSDENOPTERIN HYDROBROMIDE) — SENTYNL THERAPS INC
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA218407: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SUN PHARM INDS INC
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA201452: LENALIDOMIDE (LENALIDOMIDE) — ARROW INTL
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA BLA761044: STELARA (USTEKINUMAB) — JANSSEN BIOTECH
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA210435: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA BLA761053: OCREVUS (OCRELIZUMAB) — GENENTECH INC
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA204994: LACOSAMIDE (LACOSAMIDE) — AUROBINDO PHARMA LTD
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761045: ZIEXTENZO (PEGFILGRASTIM-BMEZ) — SANDOZ INC
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA200542: LORAZEPAM (LORAZEPAM) — RISING
fda
2026-05-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA NDA209816: NUZYRA (OMADACYCLINE TOSYLATE) — PARATEK PHARMS
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761334: ZYNYZ (RETIFANLIMAB-DLWR) — INCYTE CORP
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA211479: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — MSN
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220679: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — CENTAUR PHARMACEUTICALS PRIVATE LIMITED
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA216910: GLYCOPYRROLATE (GLYCOPYRROLATE) — QUAGEN
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA077747: OXCARBAZEPINE (OXCARBAZEPINE) — RUBICON RESEARCH
fda
2026-05-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA214398: LENALIDOMIDE (LENALIDOMIDE) — LUPIN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA090263: LEVETIRACETAM (LEVETIRACETAM) — CHARTWELL MOLECULAR
fda
2026-04-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA219941: MIRABEGRON (MIRABEGRON) — DEVA HOLDING AS
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA021732: VANTAS (HISTRELIN ACETATE) — ENDO OPERATIONS
fda
2026-05-06
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA078479: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — APOTEX
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761394: DATROWAY (DATOPOTAMAB DERUXTECAN-DLNK) — DAIICHI SANKYO INC
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220068: FOSCARNET SODIUM (FOSCARNET SODIUM) — CAPLIN
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA205081: MILNACIPRAN HYDROCHLORIDE (MILNACIPRAN HYDROCHLORIDE) — AMNEAL PHARMS
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220221: VERICIGUAT (VERICIGUAT) — TORRENT PHARMACEUTICALS LTD
fda
2026-04-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA210111: POMALIDOMIDE (POMALIDOMIDE) — BRECKENRIDGE
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA211582: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — ZYDUS PHARMS
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761147: ENNUMO (PEGFILGRASTIM-PCCG) — ACCORD BIOPHARMA INC.
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA219750: L-GLUTAMINE (L-GLUTAMINE) — STIRA
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA021891: CHILDREN'S CLARITIN (LORATADINE) — BAYER HEALTHCARE LLC
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA212975: IMATINIB MESYLATE (IMATINIB MESYLATE) — HETERO LABS LTD V
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA NDA219423: WIDAPLIK (AMLODIPINE BESYLATE) — AZURITY
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA213885: LENALIDOMIDE (LENALIDOMIDE) — EUGIA PHARMA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA216213: LENALIDOMIDE (LENALIDOMIDE) — AMNEAL
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA BLA761467: KEYTRUDA QLEX (PEMBROLIZUMAB) — MERCK SHARP DOHME
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA205772: CALCIPOTRIENE (CALCIPOTRIENE) — GLENMARK SPECLT
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA218341: OXCARBAZEPINE (OXCARBAZEPINE) — UMEDICA LABS PVT
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA216579: SYMBICORT AEROSPHERE (BUDESONIDE) — ASTRAZENECA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761342: TALVEY (TALQUETAMAB-TGVS) — JANSSEN BIOTECH
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA218214: ESTRADIOL (ESTRADIOL) — ENCUBE
fda
2026-05-11
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA208002: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — AMNEAL PHARMS CO
fda
2026-05-19
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA209817: NUZYRA (OMADACYCLINE TOSYLATE) — PARATEK PHARMS
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220747: FINERENONE (FINERENONE) — MACLEODS PHARMACEUTICALS LTD
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA207760: BOSENTAN (BOSENTAN) — ZYDUS PHARMS
fda
2026-04-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA NDA217779: RYTELO (IMETELSTAT SODIUM) — GERON
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA216964: IDVYNSO (DORAVIRINE) — MSD
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA211846: LENALIDOMIDE (LENALIDOMIDE) — SUN PHARM
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA211579: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — LUPIN
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA020785: THALOMID (THALIDOMIDE) — BRISTOL-MYERS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA220398: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — MANKIND PHARMA
fda
2026-04-16
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA219008: LAZCLUZE (LAZERTINIB MESYLATE) — JANSSEN BIOTECH
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA075327: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — ANI PHARMS
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761347: TECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) — GENENTECH INC
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA008085: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — STRIDES PHARMA INTL
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA212438: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — ENCUBE
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA209803: STEGLATRO (ERTUGLIFLOZIN) — MSD SUB MERCK
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA091291: LEVETIRACETAM (LEVETIRACETAM) — CHARTWELL RX
fda
2026-04-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA091655: ESCITALOPRAM OXALATE (ESCITALOPRAM OXALATE) — MICRO LABS
fda
2026-04-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA219072: CARBAMAZEPINE (CARBAMAZEPINE) — YICHANG HUMANWELL
fda
2026-04-17
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA218341: OXCARBAZEPINE (OXCARBAZEPINE) — UMEDICA LABS PVT
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA217239: TORSEMIDE (TORSEMIDE) — MICRO LABS
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA BLA761291: TECVAYLI (TECLISTAMAB-CQYV) — JANSSEN BIOTECH
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA205807: GABAPENTIN (GABAPENTIN) — TEVA PHARMS USA
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761100: ONTRUZANT (TRASTUZUMAB-DTTB) — SAMSUNG BIOEPIS CO LTD
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA BLA761352: BIZENGRI (ZENOCUTUZUMAB-ZBCO) — MERUS N.V.
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA215217: LEVALBUTEROL HYDROCHLORIDE (LEVALBUTEROL HYDROCHLORIDE) — NEPHRON
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761170: PHESGO (PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF) — GENENTECH INC
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA062800: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — ALMAJECT
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA208047: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — DR REDDYS
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA213343: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ACCORD HLTHCARE
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA209020: OXCARBAZEPINE (OXCARBAZEPINE) — MSN
fda
2026-05-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA215575: ANDA215575 ((unspecified)) — QILU PHARM HAINAN
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA219271: CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) — HETERO LABS LIMITED
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA217772: FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE) — AUCTA
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA090169: LAMOTRIGINE (LAMOTRIGINE) — GLENMARK PHARMS LTD
fda
2026-04-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA090607: LAMOTRIGINE (LAMOTRIGINE) — ALEMBIC PHARMS LTD
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA214120: ONUREG (AZACITIDINE) — BRISTOL
fda
2026-04-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA207694: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — LUPIN
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA205519: ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) — SCIEGEN PHARMS
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220421: ANDA220421 ((unspecified)) — HETERO LABS LIMITED, VEMAGAL
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA089534: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — SUN PHARM INDUSTRIES
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA210251: BIKTARVY (BICTEGRAVIR SODIUM) — GILEAD SCIENCES INC
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761468: HEPCLUDEX (BULEVIRTIDE-GMOD) — GILEAD SCIENCES INC
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA203708: OLANZAPINE (OLANZAPINE) — AUROBINDO PHARMA LTD
fda
2026-05-26
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA203708: OLANZAPINE (OLANZAPINE) — AUROBINDO PHARMA LTD
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220499: ANDA220499 ((unspecified)) — ALEMBIC PHARMACEUTICALS LIMITED
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA077802: OXCARBAZEPINE (OXCARBAZEPINE) — GLENMARK PHARMS LTD
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA209020: OXCARBAZEPINE (OXCARBAZEPINE) — MSN
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA202426: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — APOTEX
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA219897: PIMOZIDE (PIMOZIDE) — NOVITIUM PHARMA
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA079162: TOPIRAMATE (TOPIRAMATE) — INVAGEN PHARMS
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA211536: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — CIPLA LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA021880: REVLIMID (LENALIDOMIDE) — BRISTOL MYERS SQUIBB
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA213267: THALIDOMIDE (THALIDOMIDE) — NATCO
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA078956: LAMOTRIGINE (LAMOTRIGINE) — AUROBINDO PHARMA
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA219593: PREGABALIN (PREGABALIN) — UNICHEM
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA206387: ALENDRONATE SODIUM (ALENDRONATE SODIUM) — IPCA LABS LTD
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA078885: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — SUN PHARM
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA078982: LAMOTRIGINE (LAMOTRIGINE) — GRANULES
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA020578: ZOLADEX (GOSERELIN ACETATE) — TERSERA
fda
2026-05-06
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA205402: PALIPERIDONE (PALIPERIDONE) — I3 PHARMS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA218148: ATROPINE SULFATE (ATROPINE SULFATE) — MANKIND PHARMA
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA217761: SPIRONOLACTONE (SPIRONOLACTONE) — ANNORA PHARMA
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761452: IMMGOLIS (GOLIMUMAB-SLDI) — ACCORD BIOPHARMA INC.
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA212682: NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL HYDROCHLORIDE) — PRINSTON INC
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220673: CLOMIPHENE CITRATE (CLOMIPHENE CITRATE) — ASCENT PHARMS INC
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA202811: LINZESS (LINACLOTIDE) — ABBVIE
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.63
FDA ANDA218407: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SUN PHARM INDS INC
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA090431: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — RISING
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA090505: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — IMPAX LABS INC
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220568: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — NAVINTA LLC
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA063181: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS TEVA
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA BLA761195: VYVGART (EFGARTIGIMOD ALFA) — ARGENX BV
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA022173: ZYPREXA RELPREVV (OLANZAPINE PAMOATE) — CHEPLAPHARM
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA210454: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — EUGIA PHARMA
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA217604: PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE) — AMNEAL
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA211020: BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) — GRAVITI PHARMS
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA076521: CARBIDOPA AND LEVODOPA (CARBIDOPA) — IMPAX LABS
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA077686: DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE) — ACTAVIS LABS FL INC
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA BLA761298: PAVBLU (AFLIBERCEPT-AYYH) — AMGEN INC
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA219540: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — MSN
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA091291: LEVETIRACETAM (LEVETIRACETAM) — CHARTWELL RX
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA219755: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) — INVENTIA HEALTHCARE LIMITED
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220314: SEMAGLUTIDE (SEMAGLUTIDE) — APOTEX INC
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA BLA761328: BEYFORTUS (NIRSEVIMAB-ALIP) — ASTRAZENECA AB
fda
2026-04-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA090508: FINASTERIDE (FINASTERIDE) — SUN PHARM
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA021303: ADDERALL XR 10 (AMPHETAMINE ASPARTATE) — TAKEDA PHARMS USA
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA207812: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ZYDUS PHARMS
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA040191: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — STRIDES PHARMA INTL
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA208052: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — ZYDUS PHARMS
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA050574: SANDIMMUNE (CYCLOSPORINE) — NOVARTIS
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA210275: POMALIDOMIDE (POMALIDOMIDE) — MYLAN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA216068: ENZALUTAMIDE (ENZALUTAMIDE) — SANDOZ
fda
2026-04-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA216718: SKYCLARYS (OMAVELOXOLONE) — BIOGEN US
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA210449: CANAGLIFLOZIN (CANAGLIFLOZIN) — APOTEX
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA019901: ALTACE (RAMIPRIL) — KING PHARMS LLC
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA208510: VYVANSE (LISDEXAMFETAMINE DIMESYLATE) — TAKEDA PHARMS USA
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA219835: VEPPANU (VEPDEGESTRANT) — ARVINAS OPERATIONS
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA063065: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA211135: RIOCIGUAT (RIOCIGUAT) — MSN
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA215411: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — INVENTIA HEALTHCARE LIMITED
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA090431: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — RISING
fda
2026-04-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA076780: ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — HIKMA FARMACEUTICA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220264: VERICIGUAT (VERICIGUAT) — CHANGZHOU PHARMACEUTICAL FACTORY
fda
2026-04-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA215243: RAMELTEON (RAMELTEON) — MICRO LABS
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA220313: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — AUROBINDO PHARMA
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA217554: LENALIDOMIDE (LENALIDOMIDE) — DEVA HOLDING AS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA074728: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — SANDOZ
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA207318: NUPLAZID (PIMAVANSERIN TARTRATE) — ACADIA PHARMS INC
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA212122: BREZTRI AEROSPHERE (BUDESONIDE) — ASTRAZENECA AB
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA219249: ITOVEBI (INAVOLISIB) — GENENTECH INC
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA219804: DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE (DOLUTEGRAVIR) — LACHMAN CONSULTANT SERVICES , INC.
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA078625: LAMOTRIGINE (LAMOTRIGINE) — RUBICON RESEARCH
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA219494: SPIRONOLACTONE (SPIRONOLACTONE) — GRAVITI PHARMS
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA BLA125554: OPDIVO (NIVOLUMAB) — BRISTOL MYERS SQUIBB
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA210251: BIKTARVY (BICTEGRAVIR SODIUM) — GILEAD SCIENCES INC
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA212035: ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN) — ACCORD HLTHCARE
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA212479: JYLAMVO (METHOTREXATE) — SHORLA
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA212102: FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — UCB INC
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA078257: ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) — ONESOURCE SPECIALTY
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA205105: METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) — IMPAX LABS INC
fda
2026-04-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA205571: CARBAMAZEPINE (CARBAMAZEPINE) — ZYDUS PHARMS
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA211537: DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (DAPAGLIFLOZIN) — TORRENT
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA077510: COLESTIPOL HYDROCHLORIDE (COLESTIPOL HYDROCHLORIDE) — IMPAX LABS
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA219509: PREDNISOLONE (PREDNISOLONE) — TP ANDA HOLDINGS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA BLA761340: EPYSQLI (ECULIZUMAB-AAGH) — SAMSUNG BIOEPIS CO LTD
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA078982: LAMOTRIGINE (LAMOTRIGINE) — GRANULES
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA016730: DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE) — B BRAUN
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA BLA761108: ULTOMIRIS (RAVULIZUMAB-CWVZ) — ALEXION PHARM
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA209805: STEGLUJAN (ERTUGLIFLOZIN) — MSD SUB MERCK
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA217085: ERIBULIN MESYLATE (ERIBULIN MESYLATE) — NATCO
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA090505: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — IMPAX LABS INC
fda
2026-04-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA220568: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — NAVINTA LLC
fda
2026-04-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA217477: ANDA217477 ((unspecified)) — HAINAN POLY PHARM. CO., LTD.
fda
2026-04-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA210164: POMALIDOMIDE (POMALIDOMIDE) — APOTEX
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA205519: ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) — SCIEGEN PHARMS
fda
2026-04-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA220529: BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) — YICHANG HUMANWELL
fda
2026-05-04
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA204982: PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE (PHENTERMINE HYDROCHLORIDE) — ACTAVIS LABS FL INC
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA212428: OXCARBAZEPINE (OXCARBAZEPINE) — CHARTWELL RX
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA206194: IRBESARTAN (IRBESARTAN) — HISUN PHARM HANGZHOU
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA062943: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — ALMAJECT
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA217482: CARBIDOPA AND LEVODOPA (CARBIDOPA) — RUBICON RESEARCH
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA216403: FILSPARI (SPARSENTAN) — TRAVERE
fda
2026-04-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA021121: CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — JANSSEN PHARMS
fda
2026-04-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA216993: VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — DAIICHI SANKYO INC
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA091037: VALPROIC ACID (VALPROIC ACID) — SUN PHARM INDS LTD
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA211417: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM) — MACLEODS PHARMS LTD
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220033: ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE) — ZENARA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220274: SODIUM ACETATE (SODIUM ACETATE) — EXTROVIS
fda
2026-04-17
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA204026: POMALYST (POMALIDOMIDE) — BRISTOL
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA205254: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — MYLAN LABS LTD
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA212597: PIRFENIDONE (PIRFENIDONE) — AUROBINDO PHARMA
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA211583: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — TEVA PHARMS USA INC
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA212306: XPOVIO (SELINEXOR) — KARYOPHARM THERAPS
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA075435: GABAPENTIN (GABAPENTIN) — TEVA PHARMS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%