Genentech gets FDA priority review for hemphilia A med

Genentech, a member of the Roche Group, announced tody that the FDA has accepted the company’s supplemental Biologics License Application, or sBLA, and granted Priority Review for Hemlibra 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 expected to make a decision on approval by October 4.

https://bit.ly/2kNJ6p5