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 Braftovi (encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy

April 07 2020

April 8, 2020 - Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with...

FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors

April 06 2020

LOUISVILLE, Ky., April 6, 2020 /PRNewswire/ -- HEMA Biologics, LLC, ("HEMA Biologics") today announced that the U.S. Food and Drug Administration (FDA) approved Sevenfact® [coagulation factor VIIa (recombinant)-jncw] as the first new bypassing...

Imfinzi (durvalumab) Approved in the US for Extensive-Stage Small Cell Lung Cancer

March 30 2020

30 March 2020 -- AstraZeneca’s Imfinzi (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC)...

Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

March 30 2020

INDIANAPOLIS, March 30, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection, 80 mg/mL...

FDA Approves Triferic AVNU (ferric pyrophosphate citrate), Intravenous Formulation of Triferic for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients

March 27 2020

WIXOM, Mich., March 27, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and...

FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis

March 26 2020

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis...