FDA accepts Pfizer & #039;s application for hemophilia B gene therapy fidanacogene elaparvovec

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA).
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news