The U.S. Food and Drug Administration approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis.
The U.S. Food and Drug Administration approved Evofem Biosciences Inc.’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
H. Lundbeck A/S won U.S. FDA marketing clearance for the first intravenous medication approved for the preventative treatment of migraine.
The U.S. Food and Drug Administration approved Michigan-based Esperion’s oral, once-daily, non-statin LDL-cholesterol lowering medicine Nexletol (bempedoic acid).
Seqirus snagged U.S. FDA approval for Fluad Quadrivalent, the first quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
Epizyme’s oral potent, first-in-class EZH2 inhibitor tazemetostat won accelerated approval from the U.S. Food and Drug Administration for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
ChemoCentryx and VFMCRP announced that the companies’ pivotal Phase III ADVOCATE clinical trial of avacopan for ANCA-associated vasculitis hit the study’s primary endpoints.
Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
Five Prime Therapeutics Inc. will eliminate 70 jobs while undergoing a restructuring to extend the company’s cash runway.
The U.S. Food and Drug Administration gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease.