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BioMarin Announces Incremental Progress on Biologics License Application (BLA) Review for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A Program

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today a progress update on its Biologics License Application (BLA) for valoctocogene...
Hank Fuchs Debra Charlesworth Traci Mccarty European Commission Drug Administration Biomarin Pharmaceutical Inc

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FDA Accepts BioMarin's Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A PDUFA Target Action Date is March 31, 2023 SAN RAFAEL, Calif., Oct. 12, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Fo...
United States Hank Fuchs Debra Charlesworth Traci Mccarty European Commission Drug Administration

First Gene Therapy for Adults with Severe Hemophilia A, BioMarin's ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a ...
Nordrhein Westfalen United States Johannes Oldenburg Jean Jacques Bienaim University Clinic In Bonn European Commission

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