Calendar

pharmadog

Week of Nov 17, 2025

Nov 19, 2025approval284d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

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

full page →ropinirole hydrochloride ER →fda approvals ↗

Nov 20, 2025approval283d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

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

full page →fda approvals ↗

Nov 20, 2025approval283d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Nov 20, 2025approval283d agoPOTASSIUM CHLORIDE — FDA approvalPOTASSIUM CHLORIDE

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

full page →POTASSIUM CHLORIDE →fda approvals ↗

Nov 20, 2025approval283d agoIMULDOSA (USTEKINUMAB-SRLF) — FDA approvalustekinumab biosimilar

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS

full page →ustekinumab biosimilar →fda approvals ↗

Nov 20, 2025approval283d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval283d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval283d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

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

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Nov 20, 2025approval283d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval283d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval283d agoCLOBETASOL PROPIONATE — FDA approvalClobetasol Propionate Teva

Sponsor: XIROMED. Form: AEROSOL, FOAM. Route: TOPICAL

full page →Clobetasol Propionate Teva →fda approvals ↗

Nov 21, 2025approval282d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Nov 21, 2025approval282d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

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

full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗

Nov 21, 2025approval282d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 21, 2025approval282d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Nov 21, 2025approval282d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Nov 21, 2025approval282d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Nov 21, 2025approval282d agoLIVTENCITY (MARIBAVIR) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 21, 2025approval282d agoURSODIOL — FDA approvalURSODIOL

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

full page →URSODIOL →fda approvals ↗

Nov 21, 2025approval282d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION

full page →cosibelimab →fda approvals ↗

Nov 21, 2025approval282d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 21, 2025approval282d agoFULVESTRANT — FDA approvalFULVESTRANT

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR

full page →FULVESTRANT →fda approvals ↗

Nov 21, 2025approval282d agoBACLOFEN — FDA approvalBACLOFEN

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

full page →BACLOFEN →fda approvals ↗

Nov 21, 2025approval282d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Nov 21, 2025approval282d agoAKTEN (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

Sponsor: THEA PHARMA. Form: GEL. Route: OPHTHALMIC

full page →Laryng-O-Jet →fda approvals ↗

Nov 21, 2025approval282d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 21, 2025approval282d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

Sponsor: ANDA REPOSITORY. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Nov 21, 2025approval282d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

Nov 21, 2025approval282d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

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

full page →PROPOFOL →fda approvals ↗

Nov 21, 2025approval282d agoALBUTEROL SULFATE — FDA approvalALBUTEROL SULFATE

Sponsor: CIPLA. Form: AEROSOL, METERED. Route: INHALATION

full page →ALBUTEROL SULFATE →fda approvals ↗

Nov 21, 2025approval282d agoQOLIANA (BRIMONIDINE TARTRATE) — FDA approvalLumify

Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Lumify →fda approvals ↗

Week of Nov 24, 2025

Nov 24, 2025approval279d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

Nov 24, 2025approval

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