Validations Queue

106,328 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 21, 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)
106,328
Reviewed
13
Filtered
4,152
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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
0.64
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/Longevity31%
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 BLA761089: AJOVY (FREMANEZUMAB-VFRM) — TEVA PHARMS USA
fda
2026-06-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA203985: AFINITOR DISPERZ (EVEROLIMUS) — NOVARTIS 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 ANDA202693: ACETAZOLAMIDE SODIUM (ACETAZOLAMIDE SODIUM) — AVET LIFESCIENCES
fda
2026-06-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA206142: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — NOVEL LABS INC
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA206245: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — NOVEL LABS INC
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA NDA205917: PARICALCITOL (PARICALCITOL) — HIKMA PHARMS
fda
2026-06-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA 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/Longevity31%
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/Longevity31%
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: CAVHANZA (NILOTINIB) — FLEX PHARMA
fda
2026-05-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
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/Longevity31%
0.64
FDA ANDA072854: CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) — AIPING PHARM INC
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 ANDA074653: HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) — HIKMA
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA206822: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — PHARM ASSOC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA020232: FIORICET W/ CODEINE (ACETAMINOPHEN) — ACTAVIS LABS UT INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA075977: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — TEVA
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA203601: OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE) — AVANTHI INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA206456: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — PHARMOBEDIENT
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA217042: RIFAPENTINE (RIFAPENTINE) — MACLEODS PHARMS LTD
fda
2026-06-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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%
0.64
FDA ANDA075759: BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE) — RISING
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA076258: FENTANYL-37 (FENTANYL) — MYLAN TECHNOLOGIES
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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 ANDA206142: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — NOVEL LABS INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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 ANDA204237: RABEPRAZOLE SODIUM (RABEPRAZOLE SODIUM) — RUBICON RESEARCH
fda
2026-06-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA078005: OXCARBAZEPINE (OXCARBAZEPINE) — ANI PHARMS
fda
2026-06-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA218900: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SAPTALIS PHARMS
fda
2026-06-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA220309: CABERGOLINE (CABERGOLINE) — RENATA
fda
2026-06-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA088744: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — HIKMA
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA206245: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — NOVEL LABS INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA091443: OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE) — TEVA
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA212024: LEVORPHANOL TARTRATE (LEVORPHANOL TARTRATE) — SPECGX LLC
fda
2026-06-18
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/Longevity31%
0.63
FDA NDA022334: AFINITOR (EVEROLIMUS) — NOVARTIS
fda
2026-06-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA NDA220073: ELIQUIS (APIXABAN) — BRISTOL
fda
2026-06-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA206986: HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE) — ALVOGEN
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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 ANDA220866: ANDA220866 ((unspecified)) — HETERO LABS LIMITED
fda
2026-06-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA219552: PEMIGATINIB (PEMIGATINIB) — SANDOZ INC
fda
2026-06-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA219830: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — ORIENT PHARMA
fda
2026-06-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA075182: ESTRADIOL (ESTRADIOL) — MYLAN TECHNOLOGIES
fda
2026-06-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA075929: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN) — PHARMOBEDIENT
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA074736: NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — WATSON LABS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA213906: LEVORPHANOL TARTRATE (LEVORPHANOL TARTRATE) — SUN PHARM INDS INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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 ANDA077858: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — RISING
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA211749: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — ALKEM LABS LTD
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA020883: ARGATROBAN (ARGATROBAN) — SANDOZ
fda
2026-06-16
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA076100: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — SUN PHARM INDUSTRIES
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
0.63
FDA BLA761467: KEYTRUDA QLEX (PEMBROLIZUMAB) — MERCK SHARP DOHME
fda
2026-06-12
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 ANDA077446: IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — SANDOZ
fda
2026-06-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA202142: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — MIKART
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA040893: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — GENUS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA090404: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — SENORES PHARMS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761263: LUNSUMIO VELO (MOSUNETUZUMAB-AXGB) — GENENTECH INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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 ANDA064050: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — PADAGIS US
fda
2026-06-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA204754: LEVETIRACETAM (LEVETIRACETAM) — AIPING PHARM INC
fda
2026-06-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA040203: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — ACTAVIS ELIZABETH
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA040255: OXYCODONE AND ASPIRIN (ASPIRIN) — ANI PHARMS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
0.63
FDA ANDA216772: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — UPSHER SMITH LABS
fda
2026-06-05
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA BLA761149: ENSPRYNG (SATRALIZUMAB) — GENENTECH
fda
2026-06-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA217678: BINIMETINIB (BINIMETINIB) — ALEMBIC PHARMS LTD
fda
2026-06-18
COD_BIO_002
An AI-designed Isomorphic or peer drug enters or completes Phase 1 by end 2027
Codex Research Pack
Biotech/Longevity50%
0.63
FDA ANDA040446: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — SUN PHARM INDS INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA074597: HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) — HIKMA
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA087003: ROXICET (ACETAMINOPHEN) — HIKMA
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA078778: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — SENORES PHARMS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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 NDA021529: IMPLANON (ETONOGESTREL) — ORGANON
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA077083: LEFLUNOMIDE (LEFLUNOMIDE) — BARR
fda
2026-06-02
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA NDA215383: WELIREG (BELZUTIFAN) — MERCK SHARP DOHME
fda
2026-06-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA211586: BUPRENORPHINE (BUPRENORPHINE) — AMNEAL
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA007337: PERCODAN (ASPIRIN) — ENDO OPERATIONS
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA209655: FENTANYL-100 (FENTANYL) — ZYDUS PHARMS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA089805: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — STRIDES PHARMA INTL
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA204166: METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) — VISTAPHARM LLC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA077471: HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) — GENUS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA040894: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — GENUS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA214643: DIVALPROEX SODIUM (DIVALPROEX SODIUM) — UNICHEM
fda
2026-06-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA202773: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — AVANTHI INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA 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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%
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/Longevity31%