Posted by Michael Wonder on 07 Mar 2023
BioMarin provides update on FDA review of Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023.
BioMarin Pharmaceutical today announced that it received notice this afternoon from the US FDA that the agency has extended review of the company's biologics license application for Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A.
