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 7 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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100

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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
0.63
FDA ANDA209020: OXCARBAZEPINE (OXCARBAZEPINE) — MSN
fda
2026-05-29
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA021529: IMPLANON (ETONOGESTREL) — ORGANON
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA077083: LEFLUNOMIDE (LEFLUNOMIDE) — BARR
fda
2026-06-02
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA NDA215383: WELIREG (BELZUTIFAN) — MERCK SHARP DOHME
fda
2026-06-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA211586: BUPRENORPHINE (BUPRENORPHINE) — AMNEAL
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA007337: PERCODAN (ASPIRIN) — ENDO OPERATIONS
fda
2026-06-18
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA209655: FENTANYL-100 (FENTANYL) — ZYDUS PHARMS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA089805: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — STRIDES PHARMA INTL
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA204166: METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) — VISTAPHARM LLC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA077471: HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) — GENUS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA040894: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — GENUS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA214643: DIVALPROEX SODIUM (DIVALPROEX SODIUM) — UNICHEM
fda
2026-06-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA202773: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — AVANTHI INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA202426: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — APOTEX
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA219897: PIMOZIDE (PIMOZIDE) — NOVITIUM PHARMA
fda
2026-04-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA079162: TOPIRAMATE (TOPIRAMATE) — INVAGEN PHARMS
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA211536: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — CIPLA LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA021880: REVLIMID (LENALIDOMIDE) — BRISTOL MYERS SQUIBB
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA213267: THALIDOMIDE (THALIDOMIDE) — NATCO
fda
2026-04-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA078956: LAMOTRIGINE (LAMOTRIGINE) — AUROBINDO PHARMA
fda
2026-04-09
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA219593: PREGABALIN (PREGABALIN) — UNICHEM
fda
2026-04-30
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA206387: ALENDRONATE SODIUM (ALENDRONATE SODIUM) — IPCA LABS LTD
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA078885: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — SUN PHARM
fda
2026-05-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA078982: LAMOTRIGINE (LAMOTRIGINE) — GRANULES
fda
2026-04-30
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA020578: ZOLADEX (GOSERELIN ACETATE) — TERSERA
fda
2026-05-06
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA205402: PALIPERIDONE (PALIPERIDONE) — I3 PHARMS
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA218148: ATROPINE SULFATE (ATROPINE SULFATE) — MANKIND PHARMA
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA217761: SPIRONOLACTONE (SPIRONOLACTONE) — ANNORA PHARMA
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA BLA761452: IMMGOLIS (GOLIMUMAB-SLDI) — ACCORD BIOPHARMA INC.
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA212682: NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL HYDROCHLORIDE) — PRINSTON INC
fda
2026-05-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA220673: CLOMIPHENE CITRATE (CLOMIPHENE CITRATE) — ASCENT PHARMS INC
fda
2026-05-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA202811: LINZESS (LINACLOTIDE) — ABBVIE
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA ANDA218407: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — SUN PHARM INDS INC
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.63
FDA BLA761364: IMULDOSA (USTEKINUMAB-SRLF) — ACCORD BIOPHARMA 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%
0.63
FDA ANDA075468: CLONAZEPAM (CLONAZEPAM) — RUBICON RESEARCH
fda
2026-06-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA077567: DIVALPROEX SODIUM (DIVALPROEX SODIUM) — MYLAN
fda
2026-06-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA ANDA090460: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — ZYDUS PHARMS USA INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.63
FDA NDA021288: TRELSTAR (TRIPTORELIN PAMOATE) — VERITY
fda
2026-06-26
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA090431: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — RISING
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%
0.62
FDA ANDA090505: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — IMPAX LABS 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%
0.62
FDA ANDA220568: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — NAVINTA LLC
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%
0.62
FDA ANDA063181: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS TEVA
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%
0.62
FDA BLA761195: VYVGART (EFGARTIGIMOD ALFA) — 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%
0.62
FDA NDA022173: ZYPREXA RELPREVV (OLANZAPINE PAMOATE) — CHEPLAPHARM
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%
0.62
FDA ANDA210454: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — EUGIA 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%
0.62
FDA NDA217604: PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE) — AMNEAL
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%
0.62
FDA ANDA211020: BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) — GRAVITI PHARMS
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%
0.62
FDA ANDA076521: CARBIDOPA AND LEVODOPA (CARBIDOPA) — IMPAX LABS
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 NDA022334: AFINITOR (EVEROLIMUS) — NOVARTIS
fda
2026-06-01
CMQ_026
NVIDIA silicon roadmap: Blackwell (2025) → Vera Rubin (2026) → Vera Rubin Ultra (2027) → Feynman (2028) — annual architectural cadence.
Jensen Huang
Semis83%
0.62
FDA ANDA206228: ARSENIC TRIOXIDE (ARSENIC TRIOXIDE) — ZYDUS PHARMS
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%
0.62
FDA BLA761480: RANLUSPEC (RANIBIZUMAB-HKDZ) — LUPIN LIMITED
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%
0.62
FDA ANDA216772: BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) — UPSHER SMITH LABS
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 ANDA211187: MACITENTAN (MACITENTAN) — TEVA PHARMS USA INC
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%
0.62
FDA ANDA078232: LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) — LUPIN 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%
0.62
FDA BLA125377: YERVOY (IPILIMUMAB) — BRISTOL MYERS SQUIBB
fda
2026-06-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA215230: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (BRIMONIDINE TARTRATE) — 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%
0.62
FDA NDA218784: VORANIGO (VORASIDENIB) — SERVIER
fda
2026-06-10
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA213761: OXYCODONE HYDROCHLORIDE (OXYCODONE 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%
0.62
FDA ANDA204021: 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%
0.62
FDA ANDA204459: OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE) — 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%
0.62
FDA NDA205917: PARICALCITOL (PARICALCITOL) — HIKMA PHARMS
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 ANDA202075: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — STRIDES 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 ANDA200465: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE) — MYLAN
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%
0.62
FDA ANDA075983: TRAMADOL HYDROCHLORIDE (TRAMADOL 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%
0.62
FDA ANDA077686: DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE) — ACTAVIS LABS FL 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%
0.62
FDA BLA761298: PAVBLU (AFLIBERCEPT-AYYH) — AMGEN 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%
0.62
FDA ANDA219540: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — MSN
fda
2026-04-15
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA091291: LEVETIRACETAM (LEVETIRACETAM) — CHARTWELL RX
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%
0.62
FDA ANDA219755: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) — INVENTIA HEALTHCARE LIMITED
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%
0.62
FDA ANDA220314: SEMAGLUTIDE (SEMAGLUTIDE) — APOTEX INC
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%
0.62
FDA BLA761328: BEYFORTUS (NIRSEVIMAB-ALIP) — ASTRAZENECA AB
fda
2026-04-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA090508: FINASTERIDE (FINASTERIDE) — SUN PHARM
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 NDA021303: ADDERALL XR 10 (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%
0.62
FDA ANDA207812: METHOTREXATE SODIUM (METHOTREXATE SODIUM) — ZYDUS PHARMS
fda
2026-05-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA040191: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — 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 ANDA208052: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — ZYDUS 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%
0.62
FDA NDA050574: SANDIMMUNE (CYCLOSPORINE) — NOVARTIS
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%
0.62
FDA ANDA203047: VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) — HETERO LABS LTD V
fda
2026-06-10
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA219370: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — AUSON
fda
2026-06-09
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA021078: MALARONE PEDIATRIC (ATOVAQUONE) — GLAXOSMITHKLINE
fda
2026-06-10
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA BLA761234: OPDUALAG (NIVOLUMAB) — BRISTOL MYERS SQUIBB
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 NDA021131: 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%
0.62
FDA ANDA204979: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — 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 ANDA075929: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN) — PHARMOBEDIENT
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 ANDA202116: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — 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 ANDA206885: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — MACLEODS PHARMS 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%
0.62
FDA ANDA205321: PREGABALIN (PREGABALIN) — AUROBINDO PHARMA
fda
2026-06-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA202970: LEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) — XIROMED
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%
0.62
FDA ANDA209336: FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) — SUN PHARMA CANADA
fda
2026-06-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA211729: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — GRANULES
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 ANDA210275: POMALIDOMIDE (POMALIDOMIDE) — 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%
0.62
FDA ANDA216068: ENZALUTAMIDE (ENZALUTAMIDE) — SANDOZ
fda
2026-04-20
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA216718: SKYCLARYS (OMAVELOXOLONE) — BIOGEN US
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%
0.62
FDA ANDA210449: CANAGLIFLOZIN (CANAGLIFLOZIN) — APOTEX
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%
0.62
FDA NDA019901: ALTACE (RAMIPRIL) — KING PHARMS LLC
fda
2026-05-07
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA208510: 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%
0.62
FDA NDA219835: VEPPANU (VEPDEGESTRANT) — ARVINAS OPERATIONS
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%
0.62
FDA ANDA063065: MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) — WATSON LABS
fda
2026-05-12
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA211135: RIOCIGUAT (RIOCIGUAT) — MSN
fda
2026-05-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA215411: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — INVENTIA HEALTHCARE LIMITED
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%