Another roadblock looms for BioMarin's hemophilia A gene therapy — but it might not take too long
More than two years ago, BioMarin went into a version of corporate shock when the FDA demanded to see two years of follow-up data from its Phase III trial ahead of a marketing decision for its hemophilia A gene therapy valoctocogene roxaparvovec (valrox). And Monday evening, execs put out word that the FDA has upped the ante one more time — putting a damper on any lingering hopes for a Q1 approval by the PDUFA date next year.
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