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calendar

31,077 catalysts · 18,435 approval · 4,570 device 510k · 3,381 grant · 1,935 device recall · 1,751 device pma · 1,005 recall

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soonest latest type sponsor alpha

to 2026-02-27×clear all

type

approval18,435
device 510k4,570
grant3,381
device recall1,935
device pma1,751
recall1,005
earnings4

therapy area

no tagged catalysts yet

Week of Oct 16, 2023

›Oct 19, 2023approval1049d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 19, 2023approval1049d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 19, 2023approval1049d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 19, 2023approval1049d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 19, 2023approval1049d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 19, 2023approval1049d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Week of Oct 23, 2023

›Oct 23, 2023approval1045d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Oct 23, 2023approval

Week of Oct 30, 2023

›Oct 30, 2023approval1038d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: IPCA LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

›Oct 30, 2023approval

Week of Nov 6, 2023

›Nov 6, 2023approval1031d agoIDARUBICIN HYDROCHLORIDE — FDA approvalIDARUBICIN HYDROCHLORIDE

Sponsor: PFIZER. Form: SOLUTION. Route: INTRAVENOUS

full page →IDARUBICIN HYDROCHLORIDE →fda approvals ↗

›Nov 7, 2023approval

Week of Nov 13, 2023

›Nov 14, 2023approval1023d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →upadacitinib tartrate ER →fda approvals ↗

›Nov 15, 2023approval

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page 283 of 622

1045d ago

BUDESONIDE — FDA approvalbudesonide DR

Sponsor: RISING. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →budesonide DR →fda approvals ↗

›Oct 23, 2023approval1045d agoOSELTAMIVIR PHOSPHATE — FDA approvalOSELTAMIVIR PHOSPHATE

Sponsor: AJANTA PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →OSELTAMIVIR PHOSPHATE →fda approvals ↗

›Oct 23, 2023approval1045d agoOSELTAMIVIR PHOSPHATE — FDA approvalOSELTAMIVIR PHOSPHATE

Sponsor: AJANTA PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →OSELTAMIVIR PHOSPHATE →fda approvals ↗

›Oct 23, 2023approval1045d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL

full page →amoxicillin →fda approvals ↗

›Oct 25, 2023approval1043d agoURSODIOL — FDA approvalURSODIOL

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

full page →URSODIOL →fda approvals ↗

›Oct 26, 2023approval1042d agoVABYSMO (FARICIMAB-SVOA) — FDA approvalfaricimab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INTRAVITREAL

full page →faricimab →fda approvals ↗

›Oct 26, 2023approval1042d agoOMVOH (MIRIKIZUMAB-MRKZ) — FDA approvalmirikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →mirikizumab →fda approvals ↗

›Oct 27, 2023approval1041d agoSCOPOLAMINE — FDA approvalRiconpharma LLC

Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL

full page →fda approvals ↗

›Oct 27, 2023approval1041d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗

1038d ago

SYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

›Oct 30, 2023approval1038d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →(empagliflozin + linagliptin) →fda approvals ↗

›Oct 30, 2023approval1038d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

›Oct 30, 2023approval1038d agoTRIJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin + metformin hydrochloride) ER

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + linagliptin + metformin hydrochloride) ER →fda approvals ↗

›Oct 31, 2023approval1037d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

›Oct 31, 2023approval1037d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Oct 31, 2023approval1037d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Oct 31, 2023approval1037d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

›Oct 31, 2023approval1037d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

›Oct 31, 2023approval1037d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

›Nov 1, 2023approval1036d agoVOQUEZNA (VONOPRAZAN FUMARATE) — FDA approvalvonoprazan fumarate

Sponsor: PHATHOM. Form: TABLET. Route: ORAL

full page →vonoprazan fumarate →fda approvals ↗

›Nov 1, 2023approval1036d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Nov 3, 2023approval1034d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Nov 3, 2023approval1034d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

1030d ago

KEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Nov 7, 2023approval1030d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc