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Biomarin Receives Anticipated Notification Of PDUFA Extension For Pegvaliase Biologics License Application


Friday, 22 Dec 2017 

Dec 22 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES ANTICIPATED NOTIFICATION OF PDUFA EXTENSION FOR PEGVALIASE BIOLOGICS LICENSE APPLICATION (BLA) TO MAY 28, 2018.BIOMARIN PHARMACEUTICAL INC - U.S. FDA WILL REQUIRE ADDITIONAL TIME TO COMPLETE ITS REVIEW OF BIOLOGICS LICENSE APPLICATION FOR PEGVALIASE.BIOMARIN PHARMACEUTICAL INC - ACTION GOAL DATE FOR PEGVALIASE BIOLOGICS LICENSE APPLICATION WILL BE MAY 25, 2018.