Round Two: BioMarin Resubmits Hemophilia A Gene Therapy Roctavian In US

Conditional Approval Granted In EU In August

BioMarin maintains its lead in the race to win approval for a hemophilia A gene therapy in the US by resubmitting Roctavian two years after the FDA issued a CRL in response to the original BLA.

Round 2 neon sign with a Brick Wall Background
BioMarin is making a second attempt at FDA approval • Source: Shutterstock

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