Posted by Michael Wonder on 29 Sep 2022
BioMarin resubmits biologics license application for valoctocogene roxaparvovec AAV gene therapy for severe haemophilia A to the FDA
29 September 2022 - BLA includes substantial body of data from pivotal Phase 3 and on-going Phase 1/2 studies.
BioMarin announced today that the Company resubmitted a biologics license application to the US FDA for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe haemophilia A.
