US FDA accepts Biogen BLA for rFIXFc hemophilia B treatment
This article was originally published in Scrip
Executive Summary
The US FDA has accepted for review Biogen Idec's biologics license application (BLA) for the firm's recombinant factor IX Fc fusion protein (rFIXFc) as a treatment for hemophilia B – granting a standard review, which means it could be about a year before the company hears from the agency.