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 5 of 42, 100 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
page 5 / 42
Showing on page
100

Filters

URL params control source + min-similarity threshold
Page size

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%