Tag Archives: Approves

FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy

FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy Print this page May 24, 2019 — The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe… Read More »

FDA approves expanded label for Regeneron/Sanofi’s cholesterol drug

(Reuters) – The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc’s cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events. The FDA’s decision will allow the drug, developed along with Sanofi SA, to be prescribed to reduce the overall risk of major… Read More »