(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 »
FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism Print this page March 27, 2019 — The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders… Read More »
FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease Print this page ARDSLEY, N.Y.–(BUSINESS WIRE) December 21, 2018 –Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. OFF… Read More »
(Reuters) – The U.S. Food and Drug Administration has approved Alexion Pharmaceuticals Inc’s blood disorder drug Ultomiris, the pharma regulator’s website showed on Friday. The drug aims to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, life-threatening disorder in which red blood cells divide prematurely. Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila… Read More »