Calendar

Jan 21, 2026approval202d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jan 21, 2026grant202d agoKEYSTONE SYMPOSIA — Cardiometabolism in Health and Disease

HL grant. $18,100. PI: TERRY L. SHEPPARD

full page →nih reporter ↗

Jan 22, 2026approval201d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

Jan 22, 2026approval201d agoKETOROLAC TROMETHAMINE — FDA approvalKetorolac Tromethamine Apotex

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

full page →Ketorolac Tromethamine Apotex →fda approvals ↗

Jan 22, 2026approval201d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

Jan 22, 2026approval201d agoOXAPROZIN — FDA approvalSolubiomix LLC

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 22, 2026approval201d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 22, 2026approval201d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 22, 2026approval201d agoACYCLOVIR — FDA approvalACYCLOVIR

Sponsor: APOTEX. Form: CAPSULE. Route: ORAL

full page →ACYCLOVIR →fda approvals ↗

Jan 22, 2026approval201d agoAMLODIPINE BESYLATE — FDA approvalChina Resources Saike Pharmaceutical Co Ltd

Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 22, 2026approval201d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Jan 22, 2026approval201d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

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

full page →fda approvals ↗

Jan 22, 2026approval201d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →zilucoplan →fda approvals ↗

Jan 22, 2026approval201d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 22, 2026approval201d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 22, 2026approval201d agoESTRADIOL — FDA approvalestradiol ER

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →estradiol ER →fda approvals ↗

Jan 23, 2026approval200d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Jan 23, 2026approval200d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

Jan 23, 2026approval200d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 23, 2026approval200d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: OMNIVIUM PHARMS. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Jan 23, 2026approval200d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

Sponsor: LUPIN. Form: TABLET. Route: ORAL

full page →naloxone hydrochloride →fda approvals ↗

Jan 23, 2026approval200d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

Sponsor: LUPIN. Form: TABLET. Route: ORAL

full page →naloxone hydrochloride →fda approvals ↗

Jan 23, 2026approval200d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

full page →insulin human →fda approvals ↗

Jan 23, 2026approval200d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →suzetrigine →fda approvals ↗

Jan 23, 2026grant200d agoEMORY UNIVERSITY — Contribution of cell-specific activity to functional MRIEmory University

NS grant. $577,611. PI: Shella D Keilholz

full page →nih reporter ↗

Jan 23, 2026grant200d agoCOLUMBIA UNIVERSITY HEALTH SCIENCES — Understanding kidney failure in individuals with DiGeorge syndrome

DK grant. $859,998. PI: ROSEMARY V SAMPOGNA

full page →nih reporter ↗

Jan 24, 2026approval199d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoNAPROXEN SODIUM — FDA approvalBayer HealthCare Pharmaceuticals Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoNAPROXEN SODIUM — FDA approvalBayer HealthCare Pharmaceuticals Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoNAPROXEN SODIUM — FDA approvalBayer HealthCare Pharmaceuticals Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 24, 2026approval199d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 24, 2026approval199d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 24, 2026approval199d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 25, 2026approval198d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 25, 2026approval198d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

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Week of Jan 19, 2026