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 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.

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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
0.62
FDA ANDA075211: ACYCLOVIR (ACYCLOVIR) — AUROBINDO PHARMA 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%
0.62
FDA ANDA207825: DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE) — PHARMOBEDIENT
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%
0.62
FDA NDA022434: ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN) — CIPLA
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%
0.62
FDA ANDA203046: CODEINE SULFATE (CODEINE SULFATE) — LANNETT CO 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%
0.62
FDA ANDA074951: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — STEVENS J
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%
0.62
FDA NDA211913: ABSORICA LD (ISOTRETINOIN) — SUN PHARM
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%
0.62
FDA ANDA088629: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — 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%
0.62
FDA ANDA204021: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — 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%
0.62
FDA ANDA202935: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (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%
0.62
FDA ANDA202097: FENTANYL-100 (FENTANYL) — KINDEVA
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA215960: UTEBZI (TEBIPENEM, PIVOXIL) — GLAXOSMITHKLINE LLC
fda
2026-06-17
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA202677: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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%
0.62
FDA ANDA040860: CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — INGENUS PHARMS NJ
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%
0.62
FDA ANDA210175: OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE 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%
0.62
FDA ANDA219865: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — HETERO LABS LTD VI
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA217264: ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) — MARKSANS PHARMA
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA078582: LEVETIRACETAM (LEVETIRACETAM) — STRIDES PHARMA
fda
2026-04-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA078956: LAMOTRIGINE (LAMOTRIGINE) — AUROBINDO PHARMA
fda
2026-04-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA209500: CAPLYTA (LUMATEPERONE TOSYLATE) — INTRA-CELLULAR
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA BLA761055: DUPIXENT (DUPILUMAB) — REGENERON PHARMACEUTICALS
fda
2026-04-22
COD_BIO_002
An AI-designed Isomorphic or peer drug enters or completes Phase 1 by end 2027
Codex Research Pack
Biotech/Longevity50%
0.62
FDA NDA217180: JAKAFI XR (RUXOLITINIB PHOSPHATE) — INCYTE CORPORATION
fda
2026-05-01
COD_BIO_002
An AI-designed Isomorphic or peer drug enters or completes Phase 1 by end 2027
Codex Research Pack
Biotech/Longevity50%
0.62
FDA NDA021342: LEVO-T (LEVOTHYROXINE SODIUM) — CEDIPROF INC
fda
2026-05-04
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA213929: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — LEADING
fda
2026-05-05
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA205422: REXULTI (BREXPIPRAZOLE) — OTSUKA
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA209125: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — EUGIA PHARMA
fda
2026-05-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA062801: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — ALMAJECT
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220465: ANDA220465 ((unspecified)) — SANDOZ INC
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA217482: CARBIDOPA AND LEVODOPA (CARBIDOPA) — RUBICON RESEARCH
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA021078: MALARONE PEDIATRIC (ATOVAQUONE) — GLAXOSMITHKLINE
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%
0.62
FDA ANDA077494: RISPERIDONE (RISPERIDONE) — PH HEALTH
fda
2026-06-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA204937: BUPRENORPHINE (BUPRENORPHINE) — WATSON LABS TEVA
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA040330: 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%
0.62
FDA ANDA075759: BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE) — RISING
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA040186: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — WATSON LABS
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA076560: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN) — LGM PHARMA
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%
0.62
FDA ANDA212133: 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%
0.62
FDA ANDA208593: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — ABHAI 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%
0.62
FDA ANDA040736: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — AMNEAL PHARMS NY
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%
0.62
FDA ANDA206718: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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%
0.62
FDA ANDA218359: ACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — AUROBINDO PHARMA 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%
0.62
FDA ANDA040881: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — MIKART
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA089897: METHADONE HYDROCHLORIDE INTENSOL (METHADONE 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%
0.62
FDA ANDA211484: LEVORPHANOL TARTRATE (LEVORPHANOL TARTRATE) — ACERTIS 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%
0.61
FDA NDA022454: DATSCAN (IOFLUPANE I-123) — GE HLTHCARE INC
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA219973: PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) — SHUANGCHENG
fda
2026-04-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA204687: VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — SCIEGEN PHARMS
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA BLA125514: KEYTRUDA (PEMBROLIZUMAB) — MERCK SHARP DOHME
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA020310: NIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — KRAMER
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA BLA761412: LANGLARA (INSULIN GLARGINE-ALDY) — SUNSHINE LAKE PHARMA CO LTD
fda
2026-04-29
CMQ_010
True AGI requires genuine scientific-discovery capabilities (AlphaFold-class breakthroughs) — brute-force LLM scaling alone is insufficient.
Demis Hassabis
AI49%
0.61
FDA ANDA204072: METHYLPREDNISOLONE (METHYLPREDNISOLONE) — TIANJIN TIANYAO
fda
2026-04-10
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA NDA019901: ALTACE (RAMIPRIL) — KING PHARMS LLC
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA203103: PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) — IPCA LABS LTD
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA215971: DEUTETRABENAZINE (DEUTETRABENAZINE) — AUROBINDO PHARMA LTD
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA BLA761285: WEZLANA (USTEKINUMAB-AUUB) — AMGEN INC
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA212068: VASOPRESSIN (VASOPRESSIN) — SANDOZ
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA211015: VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) — SOMERSET THERAPS LLC
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA210329: TADALAFIL (TADALAFIL) — JUBILANT GENERICS
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA062800: CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — ALMAJECT
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA219146: GADOBUTROL (GADOBUTROL) — ZENARA
fda
2026-06-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA210365: EPIDIOLEX (CANNABIDIOL) — JAZZ PHARMS RES
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%
0.61
FDA ANDA075468: CLONAZEPAM (CLONAZEPAM) — RUBICON RESEARCH
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA087393: METHADONE HYDROCHLORIDE (METHADONE 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%
0.61
FDA NDA211913: ABSORICA LD (ISOTRETINOIN) — SUN PHARM
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA040050: METHADOSE (METHADONE HYDROCHLORIDE) — 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%
0.61
FDA ANDA211748: 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%
0.61
FDA ANDA040800: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — ACTAVIS ELIZABETH
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA209036: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — ABHAI 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%
0.61
FDA ANDA211690: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — SANALUZ
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA040834: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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%
0.61
FDA ANDA040860: CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — INGENUS PHARMS NJ
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA076604: HYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — ACTAVIS LABS FL 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%
0.61
FDA ANDA040881: HYDROCODONE BITARTRATE 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%
0.61
FDA NDA203794: NUCYNTA (TAPENTADOL HYDROCHLORIDE) — COLLEGIUM PHARM 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%
0.61
FDA ANDA040894: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — GENUS
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA078769: OXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — 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%
0.61
FDA ANDA209956: POMALIDOMIDE (POMALIDOMIDE) — TEVA PHARMS USA
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA205071: MILNACIPRAN HYDROCHLORIDE (MILNACIPRAN HYDROCHLORIDE) — BRECKENRIDGE
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA NDA219293: DANZITEN (NILOTINIB TARTRATE) — AZURITY
fda
2026-04-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA205571: CARBAMAZEPINE (CARBAMAZEPINE) — ZYDUS PHARMS
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA210111: POMALIDOMIDE (POMALIDOMIDE) — BRECKENRIDGE
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA202420: CALCIUM ACETATE (CALCIUM ACETATE) — CHARTWELL MOLECULAR
fda
2026-05-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA216081: GADOBUTROL (GADOBUTROL) — HENGRUI PHARMA
fda
2026-05-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA218558: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — MICRO LABS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA219531: SDAMLO (AMLODIPINE BESYLATE) — BRILLIAN PHARMA
fda
2026-05-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA063181: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS TEVA
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA BLA761381: OPDIVO QVANTIG (NIVOLUMAB) — BRISTOL-MYERS SQUIBB
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA212428: OXCARBAZEPINE (OXCARBAZEPINE) — CHARTWELL RX
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA211026: MACITENTAN (MACITENTAN) — SEASONS BIOTECH
fda
2026-05-19
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA216988: CLONAZEPAM (CLONAZEPAM) — RUBICON RESEARCH
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA220143: ANDA220143 ((unspecified)) — HETERO LABS LIMITED
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA081099: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — BARR
fda
2026-05-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA018569: FUROSEMIDE (FUROSEMIDE) — EPIC PHARMA LLC
fda
2026-06-02
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA021909: CHILDREN'S ALLEGRA HIVES (FEXOFENADINE HYDROCHLORIDE) — CHATTEM SANOFI
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%
0.61
FDA ANDA207429: SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) — REGCON HOLDINGS
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%
0.61
FDA ANDA214470: HALOPERIDOL (HALOPERIDOL) — ALEMBIC
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%
0.61
FDA ANDA219287: GADOBUTROL (GADOBUTROL) — VIWIT PHARM
fda
2026-06-11
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA208795: OXYCODONE HYDROCHLORIDE (OXYCODONE 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%
0.61
FDA ANDA214209: SUMATRIPTAN (SUMATRIPTAN) — CIPLA
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA202214: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — TRIS PHARMA 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%
0.61
FDA ANDA087508: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — GENUS LIFESCIENCES
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%
0.61
FDA ANDA219119: TAPENTADOL HYDROCHLORIDE (TAPENTADOL HYDROCHLORIDE) — NOVITIUM PHARMA
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%
0.61
FDA ANDA090118: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — SUN PHARM INDS 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%
0.61
FDA ANDA040260: OXYCODONE AND ASPIRIN (ASPIRIN) — 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%
0.61
FDA ANDA211499: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — ABHAI 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%
0.61
FDA ANDA203494: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — AUROBINDO PHARMA 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%
0.61
FDA ANDA217596: LACOSAMIDE (LACOSAMIDE) — PROD DEVELOPMENT
fda
2026-06-15
IND_010
Autonomous orbital manufacturing (facilitated by companies like Varda Space Industries) will successfully return pharmaceutical products processed in microgravity that are commercially superior to those manufactured on Earth by 2026 — new Biotech front...
Jared Isaacman
Biotech/Longevity43%
0.61
FDA ANDA208540: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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%
0.61
FDA NDA022063: MYDAYIS (AMPHETAMINE ASPARTATE) — TAKEDA PHARMS USA
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA220313: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — AUROBINDO PHARMA
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA211489: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) — AUROBINDO PHARMA
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA074712: LACTULOSE (LACTULOSE) — CUMBERLAND PHARMS
fda
2026-04-14
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA BLA761055: DUPIXENT (DUPILUMAB) — REGENERON PHARMACEUTICALS
fda
2026-04-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA218872: LENALIDOMIDE (LENALIDOMIDE) — ACCORD HLTHCARE
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA211132: LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM) — INGENUS PHARMS LLC
fda
2026-05-05
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA NDA022433: BRILINTA (TICAGRELOR) — ASTRAZENECA
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA BLA761070: FASENRA (BENRALIZUMAB) — ASTRAZENECA AB
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA219722: L-GLUTAMINE (L-GLUTAMINE) — ANNORA PHARMA
fda
2026-05-26
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA220041: TOPIRAMATE (TOPIRAMATE) — RICONPHARMA LLC
fda
2026-05-26
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA077747: OXCARBAZEPINE (OXCARBAZEPINE) — RUBICON RESEARCH
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA BLA761354: TOFIDENCE (TOCILIZUMAB-BAVI) — BIOGEN MA
fda
2026-05-22
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA215411: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — INVENTIA HEALTHCARE LIMITED
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA021951: ABSORICA (ISOTRETINOIN) — SUN PHARM INDS 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%
0.61
FDA NDA021131: 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%
0.61
FDA ANDA200343: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — GENUS
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA089990: 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%
0.61
FDA ANDA204407: OXYCODONE 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%
0.61
FDA ANDA209021: OXYCODONE HYDROCHLORIDE (OXYCODONE 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%
0.61
FDA ANDA209036: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — ABHAI LLC
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA087508: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — GENUS LIFESCIENCES
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA211690: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — SANALUZ
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%
0.61
FDA NDA005010: DEMEROL (MEPERIDINE HYDROCHLORIDE) — 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%
0.61
FDA ANDA080448: MEPERIDINE HYDROCHLORIDE (MEPERIDINE 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%
0.61
FDA ANDA203602: MORPHINE SULFATE (MORPHINE SULFATE) — 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%
0.61
FDA ANDA074278: LEVORPHANOL TARTRATE (LEVORPHANOL TARTRATE) — 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%
0.61
FDA ANDA201013: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — AUROLIFE PHARMA 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%
0.61
FDA ANDA201448: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — SANKALP LIFECARE
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA090733: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — PH HEALTH
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA210793: NUPLAZID (PIMAVANSERIN TARTRATE) — ACADIA PHARMS INC
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA211559: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — MACLEODS PHARMS LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA214216: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (EMTRICITABINE) — MACLEODS PHARMS LTD
fda
2026-04-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA214055: SELEXIPAG (SELEXIPAG) — RK PHARMA
fda
2026-04-16
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA216370: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM) — ALEMBIC
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA208045: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — AUROBINDO PHARMA LTD
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA NDA220787: ZAYNICH (CEFEPIME HYDROCHLORIDE) — WOCKHARDT BIO AG
fda
2026-05-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA207137: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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%
0.61
FDA ANDA091440: LEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) — LUPIN LTD
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%
0.61
FDA ANDA207574: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — SANALUZ
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%
0.61
FDA ANDA206869: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — AMNEAL PHARMS NY
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA206136: PIROXICAM (PIROXICAM) — STRIDES PHARMA
fda
2026-06-25
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA218740: CETRORELIX ACETATE (CETRORELIX ACETATE) — HUMANWELL
fda
2026-04-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA076780: ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — HIKMA FARMACEUTICA
fda
2026-04-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA018900: METRO I.V. IN PLASTIC CONTAINER (METRONIDAZOLE) — B BRAUN
fda
2026-04-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA211491: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — SUN PHARM
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA218093: FLECAINIDE ACETATE (FLECAINIDE ACETATE) — OMSAV PHARMA
fda
2026-04-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA075435: GABAPENTIN (GABAPENTIN) — TEVA PHARMS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA219531: SDAMLO (AMLODIPINE BESYLATE) — BRILLIAN PHARMA
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA220717: ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) — UMEDICA LABS PVT
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA078479: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — APOTEX
fda
2026-05-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA218088: REVEFENACIN (REVEFENACIN) — LUPIN INC.
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA NDA008085: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — STRIDES PHARMA INTL
fda
2026-05-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA219319: GABAPENTIN (GABAPENTIN) — SENORES PHARMS
fda
2026-05-14
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA211747: OXCARBAZEPINE (OXCARBAZEPINE) — ZYDUS
fda
2026-05-28
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA075211: ACYCLOVIR (ACYCLOVIR) — AUROBINDO PHARMA USA
fda
2026-06-05
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA213703: CANGRELOR (CANGRELOR) — MSN
fda
2026-06-04
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA211000: MACITENTAN (MACITENTAN) — AMNEAL
fda
2026-06-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA203985: AFINITOR DISPERZ (EVEROLIMUS) — NOVARTIS PHARM
fda
2026-06-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA219165: PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) — PAI HOLDINGS
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%
0.61
FDA ANDA204234: DOXYCYCLINE (DOXYCYCLINE) — LUPIN
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%
0.61
FDA ANDA209543: BOSUTINIB MONOHYDRATE (BOSUTINIB MONOHYDRATE) — ALEMBIC
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA207137: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — AMNEAL PHARMS
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA075351: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — NOVITIUM PHARMA
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%
0.61
FDA ANDA205057: TAPENTADOL HYDROCHLORIDE (TAPENTADOL 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%
0.61
FDA ANDA208708: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — RUBICON RESEARCH
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%
0.61
FDA ANDA208540: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — ALVOGEN
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA218738: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — TEVA PHARMS INC
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA214956: GABAPENTIN (GABAPENTIN) — ASCENT PHARMS INC
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA205756: METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) — RISING
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA208055: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — TORRENT
fda
2026-04-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA021977: VYVANSE (LISDEXAMFETAMINE DIMESYLATE) — TAKEDA PHARMS USA
fda
2026-04-23
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA075388: BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) — OXFORD PHARMS
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA205806: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — DR REDDYS LABS SA
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA220326: VILOXAZINE HYDROCHLORIDE (VILOXAZINE HYDROCHLORIDE) — APPCO PHARMA LLC
fda
2026-04-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA BLA761304: VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — ARGENX BV
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA019414: CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) — BRACCO
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA203512: SPIRONOLACTONE (SPIRONOLACTONE) — ACCORD HLTHCARE
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA211035: VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) — SOMERSET
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA218566: MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) — CONCORD BIOTECH LTD
fda
2026-06-01
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA076584: ALENDRONATE SODIUM (ALENDRONATE SODIUM) — RISING
fda
2026-06-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA213511: ELUXADOLINE (ELUXADOLINE) — AUROBINDO PHARMA
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%
0.61
FDA NDA021980: FLUORESCITE (FLUORESCEIN SODIUM) — ALCON LABS INC
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%
0.61
FDA ANDA210985: METHYLPREDNISOLONE (METHYLPREDNISOLONE) — INGENUS PHARMS LLC
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%
0.61
FDA NDA022434: ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN) — CIPLA
fda
2026-06-10
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA201194: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — VISTAPHARM LLC
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA NDA022207: MORPHINE SULFATE (MORPHINE SULFATE) — 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%
0.61
FDA BLA761324: EPKINLY (EPCORITAMAB-BYSP) — GENMAB US, INC.
fda
2026-06-17
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA040355: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — STRIDES PHARMA INTL
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA202214: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — TRIS PHARMA 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%
0.61
FDA ANDA205057: TAPENTADOL HYDROCHLORIDE (TAPENTADOL HYDROCHLORIDE) — 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%
0.61
FDA ANDA217449: BALOXAVIR MARBOXIL (BALOXAVIR MARBOXIL) — NORWICH
fda
2026-06-17
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.61
FDA ANDA040838: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — PHARM ASSOC
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%