BioMarin announces advancements in FDA review of Roctavian (valoctocogene roxaparvovec) for adults with severe haemophilia A


23 November 2022 - FDA no longer plans to hold an advisory committee meeting, as previously planned, to discuss the biologics license application.

BioMarin Pharmaceutical announced advancements in the US FDA review of the biologics license application of Roctavian (valoctocogene roxaparvovec AAV gene therapy) for adults with severe haemophilia A.

Read BioMarin press release

Michael Wonder

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Michael Wonder

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US , Dossier , Gene therapy