BioMarin announces incremental progress on biologics license application review for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A program

BioMarin

7 November 2022 - FDA requests submission of upcoming 3 year data analysis from Phase 3 GENEr8-1 trial.

BioMarin Pharmaceutical announced today a progress update on its biologics license application for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A that is currently under review by the US FDA.

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Michael Wonder

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Michael Wonder

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US , Timelines , Dossier , Gene therapy