BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa™ (drisapersen) New Drug Application by the PDUFA Date

BioMarin Pharmaceutical Inc. BMRN announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.
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