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BioMarin Receives FDA Fast Track Designation for PKU Investigational Gene Therapy americanpharmaceuticalreview
October 12, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BMN 307, an investigational gene therapy for the treatment of individuals with PKU.
BioMarin to Begin Clinical Trial with BMN 307 Gene Therapy americanpharmaceuticalreview
January 17, 2020
BioMarin announced both the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. have granted the Company Investigational New Drug (IND) status and approved its Clinical Trial Application (