Calendar

Week of Nov 17, 2025

Nov 21, 2025approval281d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

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

Nov 21, 2025approval281d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

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

Nov 21, 2025approval281d agoFULVESTRANT — FDA approvalFULVESTRANT

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

Nov 21, 2025approval281d agoBACLOFEN — FDA approvalBACLOFEN

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

Nov 21, 2025approval281d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

Nov 21, 2025approval281d agoAKTEN (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

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

Nov 21, 2025approval281d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

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

Nov 21, 2025approval281d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

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

Nov 21, 2025approval281d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

Nov 21, 2025approval281d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

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

Nov 21, 2025approval281d agoALBUTEROL SULFATE — FDA approvalALBUTEROL SULFATE

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

Nov 21, 2025approval281d agoQOLIANA (BRIMONIDINE TARTRATE) — FDA approvalLumify

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

Nov 24, 2025approval278d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

Nov 24, 2025approval

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