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calendar

24,466 catalysts · 16,606 approval · 3,309 device 510k · 2,293 grant · 842 device pma · 771 device recall · 645 recall

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2026-08-31: 0 catalysts2026-09-01: 22 catalysts2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 1 catalyst2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts2026-11-23: 0 catalysts2026-11-24: 0 catalysts2026-11-25: 0 catalysts2026-11-26: 0 catalysts2026-11-27: 0 catalysts2026-11-28: 0 catalysts2026-11-29: 0 catalysts
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  • approval16,606
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  • recall645
therapy area

no tagged catalysts yet

Week of Dec 13, 2021

10
›Dec 17, 2021approval1720d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗
›Dec 17, 2021approval1720d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Dec 17, 2021approval1720d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Dec 17, 2021approval1720d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗
›Dec 17, 2021approval1720d agoYUSIMRY (ADALIMUMAB-AQVH) — FDA approvalYUSIMRY

Sponsor: COHERUS BIOSCIENCES INC. Form: INJECTABLE. Route: INJECTION

full page →YUSIMRY →fda approvals ↗
›Dec 17, 2021approval1720d agoCAPLYTA (LUMATEPERONE TOSYLATE) — FDA approvallumateperone tosylate

Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL

full page →lumateperone tosylate →fda approvals ↗
›Dec 17, 2021approval1720d agoCAPLYTA (LUMATEPERONE TOSYLATE) — FDA approvallumateperone tosylate

Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL

full page →lumateperone tosylate →fda approvals ↗
›Dec 17, 2021approval1720d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Dec 17, 2021approval1720d agoTEZSPIRE (TEZEPELUMAB-EKKO) — FDA approvaltezepelumab

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →tezepelumab →fda approvals ↗
›Dec 17, 2021approval1720d agoVYVGART (EFGARTIGIMOD ALFA) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Dec 20, 2021

14
›Dec 20, 2021approval1717d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Dec 20, 2021approval1717d agoOTEZLA (APREMILAST) — FDA approvalapremilast

Sponsor: AMGEN INC. Form: TABLET. Route: ORAL

full page →apremilast →fda approvals ↗
›Dec 20, 2021approval1717d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
›Dec 20, 2021approval1717d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗
›Dec 21, 2021approval1716d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →amivantamab →fda approvals ↗
›Dec 22, 2021approval1715d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Dec 22, 2021approval1715d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Dec 22, 2021approval1715d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗
›Dec 22, 2021approval1715d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗
›Dec 22, 2021approval1715d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗
›Dec 22, 2021approval1715d agoVALPROATE SODIUM — FDA approvalSagent Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Dec 22, 2021approval1715d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗
›Dec 22, 2021approval1715d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗
›Dec 22, 2021approval1715d agoKOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

Week of Dec 27, 2021

5
›Dec 27, 2021approval1710d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

full page →tralokinumab →fda approvals ↗
›Dec 28, 2021approval1709d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Dec 28, 2021approval1709d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

Sponsor: MAYNE PHARMA. Form: CAPSULE. Route: ORAL

full page →(estradiol + progesterone) →fda approvals ↗
›Dec 30, 2021approval1707d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Dec 30, 2021approval1707d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: TRIS PHARMA INC. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Week of Jan 3, 2022

6
›Jan 3, 2022approval1703d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗
›Jan 3, 2022approval1703d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: ALEMBIC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Jan 3, 2022approval1703d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Jan 3, 2022approval1703d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Jan 5, 2022approval1701d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗
›Jan 7, 2022approval1699d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Jan 10, 2022

15
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 10, 2022approval1696d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jan 13, 2022approval1693d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Jan 13, 2022approval1693d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jan 13, 2022approval1693d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗
›Jan 13, 2022approval1693d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗
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