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U.S. FDA declines to approve Biomarin's gene therapy for bleeding disorder

Aug 19 (Reuters) - The U.S. Food and Drug Administration has declined to approve BioMarin Pharmaceutical Inc’s gene therapy for bleeding disorder hemophilia A, citing the need for two-year data on the therapy, the drugmaker said on Wednesday.

Hemophilia A patients are at risk for painful or potentially life-threatening bleeding from even modest injuries. (Reporting by Manas Mishra in Bengaluru; Editing by Maju Samuel)

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