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calendar

18,987 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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approval18,987
phase readout7,208
device 510k5,000
grant4,728
8k filing3,603
device pma2,000
device recall2,000

recall1,126

device adverse event1,000

earnings585

therapy area

no tagged catalysts yet

Week of Nov 24, 2025

›Nov 28, 2025approval275d agoCYCLOSPORINE — FDA approvalRestasis

Sponsor: AMNEAL. Form: EMULSION. Route: OPHTHALMIC

full page →Restasis →fda approvals ↗

›Nov 28, 2025approval275d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 28, 2025approval275d agoARMLUPEG (PEGFILGRASTIM-UNNE) — FDA approvalARMLUPEG

Sponsor: LUPIN LTD. Form: INJECTION. Route: SOLUTION

full page →ARMLUPEG →fda approvals ↗

Week of Dec 1, 2025

›Dec 1, 2025approval272d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Dec 1, 2025approval

Week of Dec 8, 2025

›Dec 8, 2025approval265d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

›Dec 8, 2025approval

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page 345 of 380

272d ago

SELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Dec 1, 2025approval272d agoOMLYCLO (OMALIZUMAB-IGEC) — FDA approvalomalizumab biosimilar

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →omalizumab biosimilar →fda approvals ↗

›Dec 1, 2025approval272d agoALBUTEROL SULFATE — FDA approvalGlaxoSmithKline LLC

Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

›Dec 2, 2025approval271d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Dec 2, 2025approval271d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Dec 2, 2025approval271d agoOLANZAPINE — FDA approvalTorrent Pharma Inc

Sponsor: TORRENT PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 2, 2025approval271d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 2, 2025approval271d agoPROPOFOL — FDA approvalBika Biotechnology Guanzhou Co Ltd

Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Dec 2, 2025approval271d agoLEVETIRACETAM — FDA approvalLEVETIRACETAM

Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS

full page →LEVETIRACETAM →fda approvals ↗

›Dec 2, 2025approval271d agoSITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — FDA approvalmetformin hydrochloride ER

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →metformin hydrochloride ER →fda approvals ↗

›Dec 3, 2025approval270d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →ERTUGLIFLOZIN →fda approvals ↗

›Dec 3, 2025approval270d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: SEASONS BIOTECH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 3, 2025approval270d agoMACITENTAN — FDA approvalMACITENTAN

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →MACITENTAN →fda approvals ↗

›Dec 3, 2025approval270d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

›Dec 4, 2025approval269d agoEPLERENONE — FDA approvalEPLERENONE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →EPLERENONE →fda approvals ↗

›Dec 4, 2025approval269d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

›Dec 5, 2025approval268d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

›Dec 5, 2025approval268d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.