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Biomarin resubmits rejected hemophilia medicine in US

The FDA will now have to consider whether new long-term data is sufficient to market authorize Biomarin’s gene therapy, a potential challenger to Novo Nordisk’s bleeding disorder treatments.

Photo: Manuel Balce Ceneta/AP/Ritzau Scanpix

Just as it said it would, Biomarin has now again submitted gene therapy valoctocogene roxaparvovec, a treatment for hemophilia A, for review by the US Food and Drug Administration (FDA), a company press release announces.

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