UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.
HIV-focused ViiV Healthcare submitted a New Drug Application (NDA) to the Food and Drug Administration for potential approval of the company’s investigational combination treatment for HIV-1.
Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.
Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
Novo Nordisk submitted the company’s oral semaglutide drug, a pill that management hopes will transform the diabetes market, for approval in the United States.
Eton Pharmaceuticals Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the injectable hospital-use product candidate DS-200 via the Rolling Review process.
The U.S. FDA accepted for review Foamix Pharmaceuticals Ltd.’s New Drug Application (NDA) for FMX101 for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris.
The Food and Drug Administration accepted Sarepta Therapeutics Inc.’s New Drug Application seeking accelerated approval for golodirsen (SRP-4053), with a regulatory action date of Aug. 19, 2019.
The U.S. FDA rejected marketing approval of Alkermes’ major depressive disorder treatment ALKS-5461.