New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)

October 13 2021

KENILWORTH, N.J.--(BUSINESS WIRE) October 13, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in...

Ocular Therapeutix Announces FDA Approval of sNDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for Intracanalicular Use for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

October 11 2021

BEDFORD, Mass.--(BUSINESS WIRE)--Oct. 11, 2021-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today...

FDA Approves Tavneos (avacopan) for the Adjunctive Treatment of ANCA-Associated Vasculitis

October 08 2021

First FDA-approved orally-administered inhibitor of the complement 5a receptor SAN CARLOS, Calif., Oct. 08, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Approves Rethymic (allogeneic processed thymus tissue-agdc) One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

October 08 2021

Rethymic is the first and only FDA-approved treatment indicated for immune reconstitution in pediatric patients with congenital athymia Children with congenital athymia are born without a thymus causing severe immunodeficiency and immune...

U.S. FDA Approves Kite’s Tecartus as the First and Only CAR-T for Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

September 30 2021

SANTA MONICA, Calif.--(BUSINESS WIRE) October 01, 2021 -- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of...

FDA Approves Livmarli (maralixibat) for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome

September 29 2021

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 29, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leader in rare liver disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Livmarli (maralixibat) oral solution for...