Posted by Michael Wonder on 13 Oct 2022
FDA accepts BioMarin's biologics license application for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A
12 October 2022 - PDUFA target action date is 31 March 2023
BioMarin Pharmaceutical announced today that the US FDA accepted the Company's resubmission of the biologics license application for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe haemophilia A.
