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 3 of 12, 200 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
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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
0.63
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%
0.62
FDA NDA212728: NURTEC ODT (RIMEGEPANT SULFATE) — PFIZER
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%
0.62
FDA ANDA212682: NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL HYDROCHLORIDE) — PRINSTON INC
fda
2026-05-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA216988: CLONAZEPAM (CLONAZEPAM) — RUBICON RESEARCH
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 ANDA208002: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — AMNEAL PHARMS CO
fda
2026-05-19
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA209091: QTERN (DAPAGLIFLOZIN) — ASTRAZENECA AB
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 NDA204042: INVOKANA (CANAGLIFLOZIN) — JANSSEN PHARMS
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 ANDA218405: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — MANKIND PHARMA LTD
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 ANDA077802: OXCARBAZEPINE (OXCARBAZEPINE) — GLENMARK PHARMS 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%
0.62
FDA ANDA219865: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — HETERO LABS LTD VI
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%
0.62
FDA ANDA217264: ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) — MARKSANS 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%
0.62
FDA ANDA078582: LEVETIRACETAM (LEVETIRACETAM) — STRIDES PHARMA
fda
2026-04-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA078956: LAMOTRIGINE (LAMOTRIGINE) — AUROBINDO PHARMA
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 NDA209500: CAPLYTA (LUMATEPERONE TOSYLATE) — INTRA-CELLULAR
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA BLA761055: DUPIXENT (DUPILUMAB) — REGENERON PHARMACEUTICALS
fda
2026-04-22
COD_BIO_002
An AI-designed Isomorphic or peer drug enters or completes Phase 1 by end 2027
Codex Research Pack
Biotech/Longevity50%
0.62
FDA NDA217180: JAKAFI XR (RUXOLITINIB PHOSPHATE) — INCYTE CORPORATION
fda
2026-05-01
COD_BIO_002
An AI-designed Isomorphic or peer drug enters or completes Phase 1 by end 2027
Codex Research Pack
Biotech/Longevity50%
0.62
FDA NDA021342: LEVO-T (LEVOTHYROXINE SODIUM) — CEDIPROF INC
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 ANDA213929: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — LEADING
fda
2026-05-05
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA NDA205422: REXULTI (BREXPIPRAZOLE) — OTSUKA
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 ANDA209125: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — EUGIA PHARMA
fda
2026-05-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.62
FDA ANDA062801: 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 ANDA220465: ANDA220465 ((unspecified)) — SANDOZ 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 ANDA217482: CARBIDOPA AND LEVODOPA (CARBIDOPA) — RUBICON RESEARCH
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%
0.61
FDA NDA022454: DATSCAN (IOFLUPANE I-123) — GE HLTHCARE 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%
0.61
FDA ANDA219973: PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) — SHUANGCHENG
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%
0.61
FDA ANDA204687: VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — SCIEGEN PHARMS
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%
0.61
FDA BLA125514: KEYTRUDA (PEMBROLIZUMAB) — MERCK SHARP DOHME
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA020310: NIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — KRAMER
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%
0.61
FDA BLA761412: LANGLARA (INSULIN GLARGINE-ALDY) — SUNSHINE LAKE PHARMA CO LTD
fda
2026-04-29
CMQ_010
True AGI requires genuine scientific-discovery capabilities (AlphaFold-class breakthroughs) — brute-force LLM scaling alone is insufficient.
Demis Hassabis
AI49%
0.61
FDA ANDA204072: METHYLPREDNISOLONE (METHYLPREDNISOLONE) — TIANJIN TIANYAO
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%
0.61
FDA NDA019901: ALTACE (RAMIPRIL) — KING PHARMS LLC
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%
0.61
FDA ANDA203103: PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) — IPCA LABS 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%
0.61
FDA ANDA215971: DEUTETRABENAZINE (DEUTETRABENAZINE) — AUROBINDO PHARMA LTD
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA BLA761285: WEZLANA (USTEKINUMAB-AUUB) — AMGEN 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%
0.61
FDA ANDA212068: VASOPRESSIN (VASOPRESSIN) — 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%
0.61
FDA ANDA211015: VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) — SOMERSET THERAPS 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%
0.61
FDA ANDA210329: TADALAFIL (TADALAFIL) — JUBILANT GENERICS
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%
0.61
FDA ANDA062800: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — ALMAJECT
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA209956: POMALIDOMIDE (POMALIDOMIDE) — TEVA PHARMS USA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA205071: MILNACIPRAN HYDROCHLORIDE (MILNACIPRAN HYDROCHLORIDE) — BRECKENRIDGE
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%
0.61
FDA NDA219293: DANZITEN (NILOTINIB TARTRATE) — AZURITY
fda
2026-04-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA205571: CARBAMAZEPINE (CARBAMAZEPINE) — ZYDUS PHARMS
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA210111: POMALIDOMIDE (POMALIDOMIDE) — BRECKENRIDGE
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA202420: CALCIUM ACETATE (CALCIUM ACETATE) — CHARTWELL MOLECULAR
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA216081: GADOBUTROL (GADOBUTROL) — HENGRUI PHARMA
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%
0.61
FDA ANDA218558: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — MICRO LABS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA219531: SDAMLO (AMLODIPINE BESYLATE) — BRILLIAN PHARMA
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%
0.61
FDA ANDA063181: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS TEVA
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA BLA761381: OPDIVO QVANTIG (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%
0.61
FDA ANDA212428: OXCARBAZEPINE (OXCARBAZEPINE) — CHARTWELL RX
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA211026: MACITENTAN (MACITENTAN) — SEASONS BIOTECH
fda
2026-05-19
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA216988: CLONAZEPAM (CLONAZEPAM) — RUBICON RESEARCH
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA220143: ANDA220143 ((unspecified)) — HETERO LABS LIMITED
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA081099: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — BARR
fda
2026-05-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA018569: FUROSEMIDE (FUROSEMIDE) — EPIC PHARMA LLC
fda
2026-06-02
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA022063: MYDAYIS (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%
0.61
FDA ANDA220313: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — AUROBINDO PHARMA
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%
0.61
FDA ANDA211489: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) — AUROBINDO 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%
0.61
FDA ANDA074712: LACTULOSE (LACTULOSE) — CUMBERLAND 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%
0.61
FDA BLA761055: DUPIXENT (DUPILUMAB) — REGENERON PHARMACEUTICALS
fda
2026-04-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA218872: LENALIDOMIDE (LENALIDOMIDE) — ACCORD HLTHCARE
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA211132: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — INGENUS PHARMS LLC
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%
0.61
FDA NDA022433: BRILINTA (TICAGRELOR) — ASTRAZENECA
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA BLA761070: FASENRA (BENRALIZUMAB) — ASTRAZENECA AB
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA219722: L-GLUTAMINE (L-GLUTAMINE) — ANNORA PHARMA
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%
0.61
FDA ANDA220041: TOPIRAMATE (TOPIRAMATE) — RICONPHARMA LLC
fda
2026-05-26
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA077747: 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%
0.61
FDA BLA761354: TOFIDENCE (TOCILIZUMAB-BAVI) — BIOGEN MA
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA215411: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — INVENTIA HEALTHCARE LIMITED
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA210793: NUPLAZID (PIMAVANSERIN TARTRATE) — ACADIA PHARMS INC
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%
0.61
FDA ANDA211559: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (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%
0.61
FDA ANDA214216: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (EMTRICITABINE) — MACLEODS PHARMS LTD
fda
2026-04-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA214055: SELEXIPAG (SELEXIPAG) — RK 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%
0.61
FDA ANDA216370: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM) — ALEMBIC
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%
0.61
FDA ANDA208045: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — AUROBINDO PHARMA 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%
0.61
FDA ANDA218740: CETRORELIX ACETATE (CETRORELIX ACETATE) — HUMANWELL
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%
0.61
FDA ANDA076780: ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — HIKMA FARMACEUTICA
fda
2026-04-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA018900: METRO I.V. IN PLASTIC CONTAINER (METRONIDAZOLE) — B BRAUN
fda
2026-04-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA211491: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — SUN PHARM
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%
0.61
FDA ANDA218093: FLECAINIDE ACETATE (FLECAINIDE ACETATE) — OMSAV PHARMA
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%
0.61
FDA ANDA075435: GABAPENTIN (GABAPENTIN) — TEVA 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%
0.61
FDA NDA219531: SDAMLO (AMLODIPINE BESYLATE) — BRILLIAN PHARMA
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA220717: ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) — UMEDICA LABS PVT
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA078479: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — APOTEX
fda
2026-05-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA218088: REVEFENACIN (REVEFENACIN) — LUPIN 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%
0.61
FDA NDA008085: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — STRIDES PHARMA INTL
fda
2026-05-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA219319: GABAPENTIN (GABAPENTIN) — SENORES PHARMS
fda
2026-05-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA211747: OXCARBAZEPINE (OXCARBAZEPINE) — ZYDUS
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%
0.61
FDA ANDA218738: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — TEVA PHARMS 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%
0.61
FDA ANDA214956: GABAPENTIN (GABAPENTIN) — ASCENT PHARMS INC
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA205756: METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) — RISING
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA208055: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — TORRENT
fda
2026-04-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA NDA021977: 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%
0.61
FDA ANDA075388: BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) — OXFORD PHARMS
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA205806: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — DR REDDYS LABS 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%
0.61
FDA ANDA220326: VILOXAZINE HYDROCHLORIDE (VILOXAZINE HYDROCHLORIDE) — APPCO PHARMA LLC
fda
2026-04-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA BLA761304: VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — 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%
0.61
FDA NDA019414: CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) — BRACCO
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity36%
0.61
FDA ANDA203512: SPIRONOLACTONE (SPIRONOLACTONE) — ACCORD HLTHCARE
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%
0.61
FDA ANDA211035: VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) — SOMERSET
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%
0.61
FDA NDA206628: DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE) — HQ SPCLT PHARMA
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%