BioMarin Pharma Announces Approval For VOXZOGO In Europe - Quick Facts

BioMarin Pharmaceutical Inc. (BMRN) said the European Commission has granted marketing authorization for VOXZOGO (vosoritide). It is the first medicine to be approved to treat children with achondroplasia in Europe. Achondroplasia is the most common cause of dwarfism.

BioMarin Pharma noted that the New Drug Application for Voxzogo is under review by the FDA with a Prescription Drug User Fee Act target action date of November 20, 2021. In January 2021, the NDA for Voxzogo had been granted priority review designation.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U. S. Food and Drug Administration or FDA has issued a public health alert against Fulvic Care Powder and Tablets from Ontario, Canada -based Black Oxygen Organics due to elevated levels of lead and arsenic. The agency advised consumers not to use Fulvic Care Powder and Tablets from Black Oxygen or give the products to pets due to elevated levels of lead and arsenic. Alexander & Hornung, a business unit of Perdue Premium Meat Co., Inc., is recalling around 234,391 pounds of fully cooked pork products citing possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced. The recall involves ham and pepperoni products that come under various brands and produced on various dates. Sandoz, Inc., an unit of Novartis AG, is recalling one lot of deep vein thrombosis (DVT) medication Enoxaparin Sodium in the form of injection for the potential exposure to high temperatures that may have impacted product effectiveness, the U.S. Food and Drug Administration or FDA said in a statement.
Follow RTT