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 1 of 42, 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)
106,328
Reviewed
13
Filtered
4,152
page 1 / 42
Showing on page
100

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URL params control source + min-similarity threshold
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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
0.71
FDA ANDA212336: ANDA212336 ((unspecified)) — DR REDDYS LABS LTD
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%
0.71
FDA ANDA220866: ANDA220866 ((unspecified)) — HETERO LABS LIMITED
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%
0.70
FDA ANDA214618: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
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%
0.70
FDA ANDA211182: ANDA211182 ((unspecified)) — HETERO LABS LTD V
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%
0.69
FDA NDA220442: XOCOVA (ENSITRELVIR) — SHIONOGI
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%
0.69
FDA ANDA213093: ANDA213093 ((unspecified)) — QILU PHARM CO LTD
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%
0.69
FDA ANDA201452: LENALIDOMIDE (LENALIDOMIDE) — ARROW INTL
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%
0.69
FDA ANDA217678: BINIMETINIB (BINIMETINIB) — ALEMBIC 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%
0.69
FDA ANDA216213: LENALIDOMIDE (LENALIDOMIDE) — AMNEAL
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%
0.69
FDA ANDA217596: LACOSAMIDE (LACOSAMIDE) — PROD DEVELOPMENT
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%
0.69
FDA NDA218197: TRUQAP (CAPIVASERTIB) — ASTRAZENECA
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%
0.69
FDA NDA217180: JAKAFI XR (RUXOLITINIB PHOSPHATE) — INCYTE CORPORATION
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%
0.69
FDA NDA020515: ZOLADEX (GOSERELIN) — TERSERA
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%
0.69
FDA ANDA210236: POMALIDOMIDE (POMALIDOMIDE) — HETERO LABS LTD V
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%
0.69
FDA ANDA220499: ANDA220499 ((unspecified)) — ALEMBIC PHARMACEUTICALS LIMITED
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.69
FDA ANDA212414: LENALIDOMIDE (LENALIDOMIDE) — HETERO LABS LTD V
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%
0.68
FDA ANDA208539: TICAGRELOR (TICAGRELOR) — MICRO LABS
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%
0.68
FDA ANDA210480: LENALIDOMIDE (LENALIDOMIDE) — ALVOGEN
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%
0.68
FDA ANDA220421: ANDA220421 ((unspecified)) — HETERO LABS LIMITED, VEMAGAL
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%
0.68
FDA ANDA217299: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — MSN
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%
0.68
FDA ANDA208869: RUXOLITINIB (RUXOLITINIB) — APOTEX INC
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%
0.68
FDA ANDA217265: LENALIDOMIDE (LENALIDOMIDE) — QILU
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%
0.68
FDA ANDA203364: MESNA (MESNA) — 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%
0.68
FDA NDA214120: ONUREG (AZACITIDINE) — BRISTOL
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%
0.68
FDA ANDA219346: ANDA219346 ((unspecified)) — SANDOZ INC
fda
2026-05-12
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA217281: LENALIDOMIDE (LENALIDOMIDE) — NOVUGEN
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%
0.68
FDA NDA217379: CAVHANZA (NILOTINIB) — FLEX PHARMA
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%
0.68
FDA ANDA219552: PEMIGATINIB (PEMIGATINIB) — SANDOZ INC
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%
0.68
FDA NDA218784: VORANIGO (VORASIDENIB) — SERVIER
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%
0.68
FDA ANDA209624: BOSUTINIB (BOSUTINIB MONOHYDRATE) — MSN
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%
0.68
FDA BLA761070: FASENRA (BENRALIZUMAB) — ASTRAZENECA AB
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA204754: LEVETIRACETAM (LEVETIRACETAM) — AIPING PHARM 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%
0.68
FDA NDA212576: INQOVI (CEDAZURIDINE) — TAIHO ONCOLOGY
fda
2026-05-13
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA218096: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — APOTEX
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%
0.68
FDA ANDA218821: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — CONCORD BIOTECH LTD
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%
0.68
FDA ANDA202076: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — 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%
0.68
FDA ANDA204949: AZACITIDINE (AZACITIDINE) — PHARMOBEDIENT
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%
0.68
FDA NDA220436: NAVITRUX (FOSAPREPITANT) — AVYXA HOLDINGS
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%
0.68
FDA ANDA220143: ANDA220143 ((unspecified)) — HETERO LABS LIMITED
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA217298: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — MSN
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%
0.68
FDA ANDA209738: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — MICRO LABS
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%
0.68
FDA ANDA209348: LENALIDOMIDE (LENALIDOMIDE) — DR REDDYS
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%
0.68
FDA NDA019726: ZOLADEX (GOSERELIN ACETATE) — TERSERA
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%
0.68
FDA ANDA212975: IMATINIB MESYLATE (IMATINIB MESYLATE) — HETERO LABS LTD V
fda
2026-05-22
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA ANDA220104: MIRTAZAPINE (MIRTAZAPINE) — MICRO LABS
fda
2026-05-19
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA BLA761324: EPKINLY (EPCORITAMAB-BYSP) — GENMAB US, INC.
fda
2026-06-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA NDA216403: FILSPARI (SPARSENTAN) — TRAVERE
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%
0.68
FDA ANDA220221: VERICIGUAT (VERICIGUAT) — TORRENT PHARMACEUTICALS LTD
fda
2026-04-20
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.68
FDA BLA761055: DUPIXENT (DUPILUMAB) — REGENERON PHARMACEUTICALS
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%
0.67
FDA ANDA079162: TOPIRAMATE (TOPIRAMATE) — INVAGEN PHARMS
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA207110: BOSENTAN (BOSENTAN) — WATSON LABS INC
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%
0.67
FDA NDA207223: DIACOMIT (STIRIPENTOL) — BIOCODEX SA
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA205254: ZOLEDRONIC ACID (ZOLEDRONIC ACID) — MYLAN 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%
0.67
FDA ANDA215356: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — AUROBINDO PHARMA LTD
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%
0.67
FDA ANDA220458: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — APOTEX
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%
0.67
FDA ANDA210692: ATOVAQUONE (ATOVAQUONE) — HETERO LABS LTD III
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%
0.67
FDA NDA210655: PERSERIS KIT (RISPERIDONE) — INDIVIOR
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%
0.67
FDA ANDA090263: LEVETIRACETAM (LEVETIRACETAM) — CHARTWELL MOLECULAR
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%
0.67
FDA ANDA213405: LENALIDOMIDE (LENALIDOMIDE) — TORRENT
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%
0.67
FDA NDA218316: WEGOVY (SEMAGLUTIDE) — NOVO
fda
2026-06-18
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA022334: AFINITOR (EVEROLIMUS) — NOVARTIS
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%
0.67
FDA BLA761063: EMGALITY (GALCANEZUMAB-GNLM) — ELI LILLY AND CO
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%
0.67
FDA ANDA211000: MACITENTAN (MACITENTAN) — AMNEAL
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%
0.67
FDA ANDA214209: SUMATRIPTAN (SUMATRIPTAN) — CIPLA
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%
0.67
FDA BLA761328: BEYFORTUS (NIRSEVIMAB-ALIP) — ASTRAZENECA AB
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%
0.67
FDA ANDA073484: VALPROIC ACID (VALPROIC ACID) — BIONPHARMA
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%
0.67
FDA ANDA216068: ENZALUTAMIDE (ENZALUTAMIDE) — SANDOZ
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%
0.67
FDA ANDA213165: LENALIDOMIDE (LENALIDOMIDE) — CIPLA
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%
0.67
FDA ANDA214398: LENALIDOMIDE (LENALIDOMIDE) — LUPIN
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%
0.67
FDA ANDA211545: DAPAGLIFLOZIN (DAPAGLIFLOZIN) — ALKEM LABS LTD
fda
2026-04-06
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA213912: LENALIDOMIDE (LENALIDOMIDE) — MYLAN
fda
2026-04-27
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA090508: FINASTERIDE (FINASTERIDE) — SUN PHARM
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%
0.67
FDA ANDA204345: CAPECITABINE (CAPECITABINE) — DR REDDYS
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%
0.67
FDA ANDA218488: EVEROLIMUS (EVEROLIMUS) — APOTEX
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%
0.67
FDA ANDA215552: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — YAOPHARMA CO LTD
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%
0.67
FDA ANDA219413: ANDA219413 ((unspecified)) — TEVA PHARMACEUTICALS, 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%
0.67
FDA ANDA215243: RAMELTEON (RAMELTEON) — MICRO LABS
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%
0.67
FDA BLA761451: SAPHNELO (ANIFROLIMAB-FNIA) — ASTRAZENECA AB
fda
2026-04-24
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA NDA020578: ZOLADEX (GOSERELIN ACETATE) — TERSERA
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%
0.67
FDA ANDA211026: MACITENTAN (MACITENTAN) — SEASONS BIOTECH
fda
2026-05-19
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA209829: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — ZYDUS PHARMS
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%
0.67
FDA NDA206321: SAXENDA (LIRAGLUTIDE) — NOVO
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%
0.67
FDA ANDA040186: MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) — WATSON LABS
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%
0.67
FDA NDA218754: APREPITANT (APREPITANT) — AZURITY
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%
0.67
FDA ANDA220264: VERICIGUAT (VERICIGUAT) — CHANGZHOU PHARMACEUTICAL FACTORY
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%
0.67
FDA ANDA211506: DAPAGLIFLOZIN (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%
0.67
FDA NDA022433: BRILINTA (TICAGRELOR) — ASTRAZENECA
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%
0.67
FDA ANDA208371: ABIRATERONE ACETATE (ABIRATERONE ACETATE) — RISING
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%
0.67
FDA ANDA218722: SOLRIAMFETOL HYDROCHLORIDE (SOLRIAMFETOL HYDROCHLORIDE) — ALKEM LABS LTD
fda
2026-06-17
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA078582: LEVETIRACETAM (LEVETIRACETAM) — STRIDES PHARMA
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%
0.67
FDA ANDA204741: CAPECITABINE (CAPECITABINE) — AMNEAL 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%
0.67
FDA ANDA219189: GALLIUM GA-68 GOZETOTIDE (GALLIUM GA-68 GOZETOTIDE) — IONETIX
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%
0.67
FDA NDA220482: NDA220482 ((unspecified)) — HAISCO PHARMACEUTICAL GROUP CO LTD
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%
0.67
FDA ANDA219530: TOFACITINIB CITRATE (TOFACITINIB CITRATE) — MACLEODS PHARMS LTD
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%
0.67
FDA ANDA216410: GALLIUM GA 68 GOZETOTIDE (GALLIUM GA-68 GOZETOTIDE) — RADIOMEDIX
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%
0.67
FDA NDA206709: DIACOMIT (STIRIPENTOL) — BIOCODEX SA
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA215336: LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) — AMNEAL
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%
0.67
FDA NDA219249: ITOVEBI (INAVOLISIB) — GENENTECH INC
fda
2026-04-15
COD_BIO_001
FDA finalizes or materially advances AI-for-drug-submission guidance by end 2026
Codex Research Pack
Biotech/Longevity47%
0.67
FDA ANDA207760: BOSENTAN (BOSENTAN) — ZYDUS 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%
0.67
FDA ANDA217554: LENALIDOMIDE (LENALIDOMIDE) — DEVA HOLDING AS
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%