FDA Grants Priority Review to Genentech's HEMLIBRA for People with Hemophilia A without Factor VIII Inhibitors
Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration has accepted the company’s supplemental Biologics License Application and granted Priority Review for HEMLIBRA Â for adults and children with hemophilia A without factor VIII inhibitors. The sBLA is based on data from the Phase III HAVEN 3 study. The FDA is […]