FDA Accepts Bayer’s Application for New Hemophilia Treatment

March 6, 2015

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry™, for the treatment of hemophilia A in children and adults. “Bayer is committed to continually […]

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