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Roctavian (valoctocogene roxaparvovec-rvox) – New orphan drug approval

June 29, 2023 - BioMarin announced the FDA approval of Roctavian (valoctocogene roxaparvovec-rvox), for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.

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