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BioMarin resubmits haemophilia A gene therapy to the EMA pharmatimes
June 30, 2021
BioMarin has resubmitted a marketing authorisation application (MAA) for its haemophilia A gene therapy valoctocogene roxaparvovec to the European Medicines Agency (EMA), the company announced 28th.
BioMarin Announces RMAT Designation Granted to Valoctocogene Roxaparvovec for Hemophilia A americanpharmaceuticalreview
March 11, 2021
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe ...
BioMarin Receives CRL for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A americanpharmaceuticalreview
August 21, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A.
Valoctocogene Roxaparvovec BLA Accepted for Priority Review by FDA americanpharmaceuticalreview
March 09, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) to the FDA for its investigational AAV5 gene therapy ...
BioMarin Announces Valoctocogene Roxaparvovec Gene Therapy Study in Severe Hemophilia A Met Pre-Specified Criteria americanpharmaceuticalreview
May 29, 2019
BioMarin Pharmaceutical announced its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A achieved pre-specified clinical criteria for regulatory review in the U.S. and Europe.
BioMarin Announces First Patient Dosed in Valoctocogene Roxaparvovec Study americanpharmaceuticalreview
May 18, 2018
BioMarin Pharmaceutical has dosed the first patient in a Phase 1/2 study (BMN 270-203) evaluating its investigational gene therapy, valoctocogene roxaparvovec, in severe hemophilia A patients with pre-existing AAV5 antibodies.