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 2 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
page 2 / 21
Showing on page
200

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
0.65
FDA ANDA210386: CANAGLIFLOZIN (CANAGLIFLOZIN) — AUROBINDO PHARMA LTD
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA020941: ABREVA (DOCOSANOL) — HALEON US HOLDINGS
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA215256: WEGOVY (SEMAGLUTIDE) — NOVO
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220137: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SOMERSET THERAPS LLC
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA BLA761309: COLUMVI (GLOFITAMAB-GXBM) — GENENTECH INC
fda
2026-06-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA208869: RUXOLITINIB (RUXOLITINIB) — APOTEX INC
fda
2026-06-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA213885: LENALIDOMIDE (LENALIDOMIDE) — EUGIA PHARMA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219271: CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) — HETERO LABS LIMITED
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA213267: THALIDOMIDE (THALIDOMIDE) — NATCO
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA091541: LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) — MICRO LABS
fda
2026-04-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA213929: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — LEADING
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA021488: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761032: SILIQ (BRODALUMAB) — VALEANT LUXEMBOURG
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761304: VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — ARGENX BV
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761381: OPDIVO QVANTIG (NIVOLUMAB) — BRISTOL-MYERS SQUIBB
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA200880: ACETAZOLAMIDE SODIUM (ACETAZOLAMIDE SODIUM) — MYLAN ASI
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA217497: TRETINOIN (TRETINOIN) — AMNEAL
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA077420: LAMOTRIGINE (LAMOTRIGINE) — RISING
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220043: VORICONAZOLE (VORICONAZOLE) — HAINAN POLY PHARM
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215552: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — YAOPHARMA CO LTD
fda
2026-06-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA BLA761306: EBGLYSS (LEBRIKIZUMAB-LBKZ) — ELI LILLY AND CO
fda
2026-06-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211312: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — SANDOZ
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA209956: POMALIDOMIDE (POMALIDOMIDE) — TEVA PHARMS USA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220326: VILOXAZINE HYDROCHLORIDE (VILOXAZINE HYDROCHLORIDE) — APPCO PHARMA LLC
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761468: HEPCLUDEX (BULEVIRTIDE-GMOD) — GILEAD SCIENCES INC
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA219943: KOSELUGO (SELUMETINIB) — ASTRAZENECA
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA208400: XATMEP (METHOTREXATE SODIUM) — AZURITY
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA220458: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — APOTEX
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA210275: POMALIDOMIDE (POMALIDOMIDE) — MYLAN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA205035: TRANEXAMIC ACID (TRANEXAMIC ACID) — EUGIA PHARMA
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA071130: HALOPERIDOL (HALOPERIDOL) — AIPING PHARM INC
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211533: DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (DAPAGLIFLOZIN) — MSN
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211563: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — ALKEM LABS LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA214216: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (EMTRICITABINE) — MACLEODS PHARMS LTD
fda
2026-04-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA205402: PALIPERIDONE (PALIPERIDONE) — I3 PHARMS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA207740: OMEPRAZOLE (OMEPRAZOLE) — DR REDDYS
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211135: RIOCIGUAT (RIOCIGUAT) — MSN
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA210215: AMANTADINE HYDROCHLORIDE (AMANTADINE HYDROCHLORIDE) — POM PHARMA
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA202811: LINZESS (LINACLOTIDE) — ABBVIE
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA088640: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — BARR
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%
0.65
FDA NDA018900: METRO I.V. IN PLASTIC CONTAINER (METRONIDAZOLE) — B BRAUN
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA214956: GABAPENTIN (GABAPENTIN) — ASCENT PHARMS INC
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA021880: REVLIMID (LENALIDOMIDE) — BRISTOL MYERS SQUIBB
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA219540: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — MSN
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA072736: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA075471: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — MEITHEAL
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA218691: CEFIXIME (CEFIXIME) — FDC LTD
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219869: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — HETERO LABS LTD V
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA214056: ONAPGO (APOMORPHINE HYDROCHLORIDE) — MDD US
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA761369: HYMPAVZI (MARSTACIMAB-HNCQ) — PFIZER INC
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%
0.65
FDA ANDA074521: DIPYRIDAMOLE (DIPYRIDAMOLE) — HIKMA
fda
2026-06-04
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA213414: DAPSONE (DAPSONE) — ALEMBIC
fda
2026-06-25
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA090170: LAMOTRIGINE (LAMOTRIGINE) — UNICHEM LABS LTD
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA072733: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA204345: CAPECITABINE (CAPECITABINE) — DR REDDYS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA BLA761195: VYVGART (EFGARTIGIMOD ALFA) — ARGENX BV
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA217265: LENALIDOMIDE (LENALIDOMIDE) — QILU
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA209348: LENALIDOMIDE (LENALIDOMIDE) — DR REDDYS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA206371: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — MICRO LABS
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215759: LENALIDOMIDE (LENALIDOMIDE) — BIOCON PHARMA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA207974: FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD HYDROCHLORIDE) — ALEMBIC
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA BLA103792: HERCEPTIN (TRASTUZUMAB) — GENENTECH
fda
2026-05-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA216453: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ELITE LABS INC
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219395: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SPECGX LLC
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA BLA761458: EXDENSUR (DEPEMOKIMAB-ULAA) — GLAXOSMITHKLINE LLC
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%
0.65
FDA ANDA202097: FENTANYL-100 (FENTANYL) — KINDEVA
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%
0.65
FDA ANDA201952: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — MICRO LABS LTD INDIA
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%
0.65
FDA NDA218275: ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) — ISTX
fda
2026-06-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA207037: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — ALKEM LABS LTD
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA212773: IMATINIB MESYLATE (IMATINIB MESYLATE) — EUGIA PHARMA
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA219408: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — SCIEGEN PHARMACEUTICALS INC
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA218897: VALSARTAN (VALSARTAN) — LAURUS
fda
2026-04-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA215759: LENALIDOMIDE (LENALIDOMIDE) — BIOCON PHARMA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA208055: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — TORRENT
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA063065: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA217432: FAMOTIDINE (FAMOTIDINE) — LUPIN
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA NDA218197: TRUQAP (CAPIVASERTIB) — ASTRAZENECA
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA NDA212102: FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — UCB INC
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA211747: OXCARBAZEPINE (OXCARBAZEPINE) — ZYDUS
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA NDA202293: FARXIGA (DAPAGLIFLOZIN) — ASTRAZENECA AB
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.65
FDA ANDA202778: DOXYCYCLINE (DOXYCYCLINE) — STRIDES 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%
0.65
FDA ANDA209624: BOSUTINIB (BOSUTINIB MONOHYDRATE) — MSN
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.65
FDA ANDA219052: PERAMPANEL (PERAMPANEL) — TARO
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%
0.64
FDA ANDA208539: TICAGRELOR (TICAGRELOR) — MICRO LABS
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA218441: SITAGLIPTIN (SITAGLIPTIN) — BIOCON PHARMA LTD
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA209500: CAPLYTA (LUMATEPERONE TOSYLATE) — INTRA-CELLULAR
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA214618: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA215826: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — ZYDUS PHARMS
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA218488: EVEROLIMUS (EVEROLIMUS) — APOTEX
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA NDA207947: UPTRAVI (SELEXIPAG) — ACTELION
fda
2026-05-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220104: MIRTAZAPINE (MIRTAZAPINE) — MICRO LABS
fda
2026-05-19
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA NDA018569: FUROSEMIDE (FUROSEMIDE) — EPIC PHARMA LLC
fda
2026-06-02
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA078316: OXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — BARR 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%
0.64
FDA ANDA090964: OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE 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 ANDA089828: 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%
0.64
FDA ANDA211825: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — UNICHEM
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 ANDA087006: ACETAMINOPHEN 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%
0.64
FDA ANDA211535: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — CIPLA
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219593: PREGABALIN (PREGABALIN) — UNICHEM
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA212963: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — EUGIA PHARMA
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA214376: MYCOPHENOLATE SODIUM (MYCOPHENOLATE SODIUM) — YICHANG HUMANWELL
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA213603: GABAPENTIN (GABAPENTIN) — ZHEJIANG YONGTAI
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA201446: FALLBACK SOLO (LEVONORGESTREL) — LUPIN
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA021343: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA021379: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA204741: CAPECITABINE (CAPECITABINE) — AMNEAL PHARMS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA079204: LAMOTRIGINE (LAMOTRIGINE) — TARO
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA214275: UPTRAVI (SELEXIPAG) — ACTELION
fda
2026-05-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA217552: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ALEMBIC
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA217873: SUCCINYLCHOLINE CHLORIDE (SUCCINYLCHOLINE CHLORIDE) — STERISCIENCE
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%
0.64
FDA NDA019193: PROVOCHOLINE (METHACHOLINE CHLORIDE) — METHAPHARM
fda
2026-06-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219370: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — AUSON
fda
2026-06-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA204603: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — 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%
0.64
FDA NDA204017: TWIRLA (ETHINYL ESTRADIOL) — AGILE
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 ANDA040110: 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%
0.64
FDA ANDA217449: BALOXAVIR MARBOXIL (BALOXAVIR MARBOXIL) — NORWICH
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 ANDA204649: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN) — QUAGEN
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 BLA761139: ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — DAIICHI SANKYO
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA076781: ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) — HIKMA FARMACEUTICA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA213165: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA BLA125504: COSENTYX (SECUKINUMAB) — NOVARTIS PHARMS CORP
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA211482: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — AJANTA PHARMA LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA125554: OPDIVO (NIVOLUMAB) — BRISTOL MYERS SQUIBB
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA209125: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — EUGIA PHARMA
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA213362: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — DAITO
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA125166: SOLIRIS (ECULIZUMAB) — ALEXION PHARM
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA203047: VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) — HETERO LABS LTD V
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%
0.64
FDA NDA021130: ZYVOX (LINEZOLID) — PFIZER
fda
2026-06-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA021366: CRESTOR (ROSUVASTATIN CALCIUM) — ASTRAZENECA
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA125261: STELARA (USTEKINUMAB) — CENTOCOR ORTHO BIOTECH INC
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA207110: BOSENTAN (BOSENTAN) — WATSON LABS INC
fda
2026-04-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA213912: LENALIDOMIDE (LENALIDOMIDE) — MYLAN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA NDA021731: ELIGARD KIT (LEUPROLIDE ACETATE) — TOLMAR
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210689: FOSAPREPITANT DIMEGLUMINE (FOSAPREPITANT DIMEGLUMINE) — LUPIN
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA078480: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — APOTEX
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA217186: CREXONT (CARBIDOPA) — IMPAX
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220709: DEFLAZACORT (DEFLAZACORT) — CARNEGIE
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 BLA761105: SKYRIZI (RISANKIZUMAB-RZAA) — ABBVIE INC
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%
0.64
FDA ANDA205294: DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE HYDROCHLORIDE) — FDC LTD
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%
0.64
FDA ANDA218307: OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE) — ALEMBIC
fda
2026-06-25
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA091691: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — REGCON HOLDINGS
fda
2026-06-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219072: CARBAMAZEPINE (CARBAMAZEPINE) — YICHANG HUMANWELL
fda
2026-04-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA216992: DEFLAZACORT (DEFLAZACORT) — UPSHER SMITH LABS
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA218872: LENALIDOMIDE (LENALIDOMIDE) — ACCORD HLTHCARE
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA202667: COSOPT PF (DORZOLAMIDE HYDROCHLORIDE) — THEA PHARMA
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA072734: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — HIKMA
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA205422: REXULTI (BREXPIPRAZOLE) — OTSUKA
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA215276: NICOTINE POLACRILEX (NICOTINE POLACRILEX) — DR REDDYS LABS SA
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA208573: VENCLEXTA (VENETOCLAX) — ABBVIE
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA040054: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — HIKMA
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA219319: GABAPENTIN (GABAPENTIN) — SENORES PHARMS
fda
2026-05-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA077420: LAMOTRIGINE (LAMOTRIGINE) — RISING
fda
2026-05-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA081235: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — MYLAN
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA218405: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — MANKIND PHARMA LTD
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA220442: XOCOVA (ENSITRELVIR) — SHIONOGI
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 ANDA200296: RISEDRONATE SODIUM (RISEDRONATE SODIUM) — AUROBINDO PHARMA LTD
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%
0.64
FDA NDA214373: BRENZAVVY (BEXAGLIFLOZIN) — THERACOSBIO
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA201973: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — IPCA 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%
0.64
FDA ANDA217678: BINIMETINIB (BINIMETINIB) — ALEMBIC PHARMS LTD
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 ANDA205321: PREGABALIN (PREGABALIN) — AUROBINDO PHARMA
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 BLA761113: SARCLISA (ISATUXIMAB-IRFC) — SANOFI AVENTIS US
fda
2026-06-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210249: POMALIDOMIDE (POMALIDOMIDE) — EUGIA PHARMA
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA210655: PERSERIS KIT (RISPERIDONE) — INDIVIOR
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA214957: GABAPENTIN (GABAPENTIN) — ASCENT PHARMS INC
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220660: ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE) — AIZANT
fda
2026-04-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA215430: AUVELITY (BUPROPION HYDROCHLORIDE) — AXSOME
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA019010: LUPRON (LEUPROLIDE ACETATE) — ABBVIE ENDOCRINE INC
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA076958: LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) — TEVA
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220717: ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) — UMEDICA LABS PVT
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA212576: INQOVI (CEDAZURIDINE) — TAIHO ONCOLOGY
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA090382: LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) — STRIDES PHARMA
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%
0.64
FDA ANDA214590: TRETINOIN (TRETINOIN) — ALEMBIC
fda
2026-06-11
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA085106: PERCOCET (ACETAMINOPHEN) — OZANTRI
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 ANDA210506: HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) — ASCENT PHARMS 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 ANDA206914: 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 ANDA217281: LENALIDOMIDE (LENALIDOMIDE) — NOVUGEN
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA213093: ANDA213093 ((unspecified)) — QILU PHARM CO LTD
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA BLA761235: VABYSMO (FARICIMAB-SVOA) — GENENTECH INC
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA205756: METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) — RISING
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA217180: JAKAFI XR (RUXOLITINIB PHOSPHATE) — INCYTE CORPORATION
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA NDA020785: THALOMID (THALIDOMIDE) — BRISTOL-MYERS
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA210236: POMALIDOMIDE (POMALIDOMIDE) — HETERO LABS LTD V
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA BLA761034: TECENTRIQ (ATEZOLIZUMAB) — GENENTECH INC
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA212371: EMPAGLIFLOZIN (EMPAGLIFLOZIN) — AUROBINDO PHARMA LIMITED
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA220366: LACOSAMIDE (LACOSAMIDE) — STERANCO HLTHCARE
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA207717: OXCARBAZEPINE (OXCARBAZEPINE) — RUBICON RESEARCH
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA NDA209091: QTERN (DAPAGLIFLOZIN) — ASTRAZENECA AB
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA761460: DECNUPAZ (PIVEKIMAB SUNIRINE-PVZY) — ABBVIE INC
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA209286: DIVALPROEX SODIUM (DIVALPROEX SODIUM) — LUPIN
fda
2026-06-11
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA761119: VYEPTI (EPTINEZUMAB-JJMR) — Lundbeck Seattle BioPharmaceuticals, Inc.
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 ANDA212143: FOSAPREPITANT DIMEGLUMINE (FOSAPREPITANT DIMEGLUMINE) — CHIA TAI TIANQING
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%
0.64
FDA NDA021130: ZYVOX (LINEZOLID) — PFIZER
fda
2026-06-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA ANDA076003: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — AMNEAL 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%
0.64
FDA NDA215960: UTEBZI (TEBIPENEM, PIVOXIL) — GLAXOSMITHKLINE LLC
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 ANDA076914: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — GRAVITI 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%
0.64
FDA ANDA211022: LENALIDOMIDE (LENALIDOMIDE) — APOTEX
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.64
FDA BLA125409: PERJETA (PERTUZUMAB) — GENENTECH
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA206863: DALFAMPRIDINE (DALFAMPRIDINE) — ACCORD HLTHCARE
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA ANDA091655: ESCITALOPRAM OXALATE (ESCITALOPRAM OXALATE) — MICRO LABS
fda
2026-04-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.64
FDA BLA761068: CRYSVITA (BUROSUMAB-TWZA) — KYOWA KIRIN
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%