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 4 of 21, 200 rows by similarity. Adjudicating updates doc_node_links.reviewed=true with the chosen polarity, writes per-link rows to audit_log, and removes the row from this queue. Phase 4 inference will use confirmed corroborates/contradicts links as Bayesian evidence.

Pending (total)
106,328
Reviewed
13
Filtered
4,152
page 4 / 21
Showing on page
200

Filters

URL params control source + min-similarity threshold
Page size

Bulk auto-confirm by similarity threshold

Confirm or label (corroborates / contradicts) all unreviewed links above a similarity threshold in one transaction. Each affected row writes a per-link audit_log entry. Capped at 1,000 links per call. Use Preview first.

Source0 selected · 0 visible
Bulk action
SimDocSourcePredDomainPrior
0.63
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%
0.62
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 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 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%
0.62
FDA NDA209637: OZEMPIC (SEMAGLUTIDE) — NOVO
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA210692: ATOVAQUONE (ATOVAQUONE) — HETERO LABS LTD III
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 ANDA078005: OXCARBAZEPINE (OXCARBAZEPINE) — ANI PHARMS
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 ANDA200343: 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%
0.62
FDA ANDA211228: METHADONE HYDROCHLORIDE (METHADONE 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 NDA202245: CODEINE SULFATE (CODEINE 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%
0.62
FDA ANDA085106: PERCOCET (ACETAMINOPHEN) — OZANTRI
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 ANDA088629: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — ANI 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%
0.62
FDA ANDA212451: MORPHINE SULFATE (MORPHINE SULFATE) — 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%
0.62
FDA ANDA087997: 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%
0.62
FDA ANDA207808: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — RHODES 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%
0.62
FDA ANDA075968: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — GRAVITI PHARMS
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA206869: 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 ANDA210162: BUPRENORPHINE (BUPRENORPHINE) — MYLAN TECH VIATRIS
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 ANDA090431: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — RISING
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 ANDA076780: ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — HIKMA FARMACEUTICA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220264: VERICIGUAT (VERICIGUAT) — CHANGZHOU PHARMACEUTICAL FACTORY
fda
2026-04-08
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA215243: RAMELTEON (RAMELTEON) — MICRO LABS
fda
2026-06-04
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA220313: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — AUROBINDO PHARMA
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 ANDA217554: LENALIDOMIDE (LENALIDOMIDE) — DEVA HOLDING AS
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 ANDA074728: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — 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%
0.62
FDA NDA207318: NUPLAZID (PIMAVANSERIN TARTRATE) — ACADIA PHARMS INC
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 NDA212122: BREZTRI AEROSPHERE (BUDESONIDE) — ASTRAZENECA AB
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%
0.62
FDA NDA219249: ITOVEBI (INAVOLISIB) — GENENTECH INC
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 NDA219804: DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE (DOLUTEGRAVIR) — LACHMAN CONSULTANT SERVICES , INC.
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA078625: LAMOTRIGINE (LAMOTRIGINE) — RUBICON RESEARCH
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 ANDA219494: SPIRONOLACTONE (SPIRONOLACTONE) — GRAVITI PHARMS
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 BLA125554: OPDIVO (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%
0.62
FDA NDA210251: BIKTARVY (BICTEGRAVIR SODIUM) — GILEAD SCIENCES INC
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA212035: ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN) — ACCORD HLTHCARE
fda
2026-05-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA212479: JYLAMVO (METHOTREXATE) — SHORLA
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 NDA212102: FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — UCB 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 ANDA220724: ANDA220724 ((unspecified)) — ZYDUS PHARMACEUTICALS (USA) INC.
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA BLA761036: DARZALEX (DARATUMUMAB) — JANSSEN BIOTECH
fda
2026-05-28
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%
0.62
FDA ANDA076584: ALENDRONATE SODIUM (ALENDRONATE SODIUM) — RISING
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 NDA021132: 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%
0.62
FDA ANDA089351: ROXICET (ACETAMINOPHEN) — 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%
0.62
FDA ANDA203208: 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%
0.62
FDA ANDA090273: CICLOPIROX (CICLOPIROX) — GLENMARK PHARMS
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 NDA218275: ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) — ISTX
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 ANDA212173: ACYCLOVIR (ACYCLOVIR) — YILING
fda
2026-06-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA078257: ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) — ONESOURCE SPECIALTY
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%
0.62
FDA ANDA205105: METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) — IMPAX LABS INC
fda
2026-04-21
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA205571: CARBAMAZEPINE (CARBAMAZEPINE) — ZYDUS PHARMS
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%
0.62
FDA ANDA211537: DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (DAPAGLIFLOZIN) — TORRENT
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%
0.62
FDA ANDA077510: COLESTIPOL HYDROCHLORIDE (COLESTIPOL HYDROCHLORIDE) — IMPAX LABS
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%
0.62
FDA ANDA219509: PREDNISOLONE (PREDNISOLONE) — TP ANDA HOLDINGS
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%
0.62
FDA BLA761340: EPYSQLI (ECULIZUMAB-AAGH) — SAMSUNG BIOEPIS CO LTD
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 ANDA078982: LAMOTRIGINE (LAMOTRIGINE) — GRANULES
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 NDA016730: DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE) — B BRAUN
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 BLA761108: ULTOMIRIS (RAVULIZUMAB-CWVZ) — ALEXION PHARM
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA209805: STEGLUJAN (ERTUGLIFLOZIN) — MSD SUB MERCK
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA217085: ERIBULIN MESYLATE (ERIBULIN MESYLATE) — NATCO
fda
2026-06-01
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220562: EPINEPHRINE (EPINEPHRINE) — HIKMA
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 ANDA208175: PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE (PHENTERMINE HYDROCHLORIDE) — DR REDDYS LABS SA
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 ANDA207961: DABIGATRAN ETEXILATE MESYLATE (DABIGATRAN ETEXILATE MESYLATE) — HETERO LABS LTD III
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 ANDA208371: ABIRATERONE ACETATE (ABIRATERONE ACETATE) — RISING
fda
2026-06-05
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA204949: AZACITIDINE (AZACITIDINE) — PHARMOBEDIENT
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 ANDA204937: BUPRENORPHINE (BUPRENORPHINE) — WATSON LABS TEVA
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA088109: 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%
0.62
FDA ANDA079046: OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE) — 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%
0.62
FDA ANDA201295: 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%
0.62
FDA ANDA089351: ROXICET (ACETAMINOPHEN) — 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 ANDA040255: OXYCODONE AND ASPIRIN (ASPIRIN) — ANI 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%
0.62
FDA ANDA210176: 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 ANDA091308: IMIQUIMOD (IMIQUIMOD) — APOTEX INC
fda
2026-06-24
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA087003: ROXICET (ACETAMINOPHEN) — 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 ANDA087006: ACETAMINOPHEN 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 ANDA090505: DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) — IMPAX LABS INC
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 ANDA220568: GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE) — NAVINTA LLC
fda
2026-04-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA217477: ANDA217477 ((unspecified)) — HAINAN POLY PHARM. CO., LTD.
fda
2026-04-23
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA210164: POMALIDOMIDE (POMALIDOMIDE) — APOTEX
fda
2026-04-27
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA205519: ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) — SCIEGEN PHARMS
fda
2026-04-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA220529: BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) — YICHANG HUMANWELL
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 ANDA204982: PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE (PHENTERMINE HYDROCHLORIDE) — ACTAVIS LABS FL INC
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 ANDA212428: OXCARBAZEPINE (OXCARBAZEPINE) — CHARTWELL RX
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 ANDA206194: IRBESARTAN (IRBESARTAN) — HISUN PHARM HANGZHOU
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%
0.62
FDA ANDA062943: 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 ANDA217482: CARBIDOPA AND LEVODOPA (CARBIDOPA) — RUBICON RESEARCH
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA220787: ZAYNICH (CEFEPIME HYDROCHLORIDE) — WOCKHARDT BIO AG
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 ANDA219099: ROMIDEPSIN (ROMIDEPSIN) — AMNEAL
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 ANDA215939: OXCARBAZEPINE (OXCARBAZEPINE) — ANNORA PHARMA
fda
2026-05-28
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA040385: TREXALL (METHOTREXATE SODIUM) — BARR
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 ANDA040078: LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) — HOSPIRA
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 ANDA072854: CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) — AIPING PHARM INC
fda
2026-05-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA204209: ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE (ACETAMINOPHEN) — PHARMOBEDIENT
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA204603: 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 ANDA040826: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — SUN PHARM INDS 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 ANDA040119: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — PAI HOLDINGS
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 NDA214044: QDOLO (TRAMADOL HYDROCHLORIDE) — ROSEMONT
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 ANDA040535: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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 ANDA091609: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — 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%
0.62
FDA ANDA210162: BUPRENORPHINE (BUPRENORPHINE) — MYLAN TECH VIATRIS
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 NDA219304: ROMVIMZA (VIMSELTINIB) — DECIPHERA PHARMS
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 ANDA085861: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — ACTAVIS MID ATLANTIC
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 ANDA203502: METHADONE HYDROCHLORIDE (METHADONE 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 ANDA202419: DIVALPROEX SODIUM (DIVALPROEX SODIUM) — AUROBINDO PHARMA LTD
fda
2026-06-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA216403: FILSPARI (SPARSENTAN) — TRAVERE
fda
2026-04-13
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA021121: CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — JANSSEN PHARMS
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%
0.62
FDA NDA216993: VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — DAIICHI SANKYO INC
fda
2026-04-29
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA091037: VALPROIC ACID (VALPROIC ACID) — SUN PHARM INDS LTD
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%
0.62
FDA ANDA211417: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM) — MACLEODS PHARMS 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%
0.62
FDA NDA209552: ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN) — EUGIA PHARMA SPECLTS
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 NDA201743: ARGATROBAN IN DEXTROSE (ARGATROBAN) — SANDOZ
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA202593: CAPECITABINE (CAPECITABINE) — ACCORD HLTHCARE
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 ANDA205814: HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE 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 ANDA040355: 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 ANDA204407: OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — NOVEL LABS INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA040119: ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — PAI HOLDINGS
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 ANDA075964: TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) — SUN PHARM INDS INC
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA201574: MORPHINE SULFATE (MORPHINE SULFATE) — PADAGIS US
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 ANDA206420: MORPHINE SULFATE (MORPHINE SULFATE) — RHODES 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 ANDA206484: HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — UPSHER SMITH 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 ANDA220033: ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE) — ZENARA
fda
2026-04-08
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA220274: SODIUM ACETATE (SODIUM ACETATE) — EXTROVIS
fda
2026-04-17
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA204026: POMALYST (POMALIDOMIDE) — BRISTOL
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 ANDA205254: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — MYLAN LABS LTD
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 ANDA212597: PIRFENIDONE (PIRFENIDONE) — AUROBINDO PHARMA
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA211583: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN) — TEVA PHARMS USA INC
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%
0.62
FDA NDA212306: XPOVIO (SELINEXOR) — KARYOPHARM THERAPS
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 ANDA075435: GABAPENTIN (GABAPENTIN) — TEVA PHARMS
fda
2026-05-07
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA NDA212728: NURTEC ODT (RIMEGEPANT SULFATE) — PFIZER
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%
0.62
FDA ANDA212682: NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL HYDROCHLORIDE) — PRINSTON INC
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 ANDA216988: CLONAZEPAM (CLONAZEPAM) — RUBICON RESEARCH
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%
0.62
FDA ANDA208002: LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) — AMNEAL PHARMS CO
fda
2026-05-19
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA209091: QTERN (DAPAGLIFLOZIN) — ASTRAZENECA AB
fda
2026-06-03
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA NDA204042: INVOKANA (CANAGLIFLOZIN) — JANSSEN PHARMS
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.62
FDA ANDA218405: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (SITAGLIPTIN, METFORMIN HYDROCHLORIDE) — MANKIND PHARMA LTD
fda
2026-05-21
242_048
FDA will move to zero clinical trial model given enough Bayesian/computational evidence
Alex Wissner-Gross
Biotech/Longevity31%
0.62
FDA ANDA077802: OXCARBAZEPINE (OXCARBAZEPINE) — GLENMARK PHARMS LTD
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 ANDA208111: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (AZELASTINE HYDROCHLORIDE) — PADAGIS ISRAEL
fda
2026-06-03
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%