Validations Queue

108,318 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 10 of 44, 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)
108,318
Reviewed
13
Filtered
4,344
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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
0.61
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 ANDA213154: BOSENTAN (BOSENTAN) — NATCO PHARMA LTD
fda
2026-06-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
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 ANDA075972: METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — CHARTWELL
fda
2026-06-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.61
FDA ANDA073229: VALPROIC ACID (VALPROIC ACID) — CATALENT
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 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 NDA050817: CEFEPIME IN PLASTIC CONTAINER (CEFEPIME HYDROCHLORIDE) — BAXTER HLTHCARE
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 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 ANDA204752: 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%
0.61
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%