August 29, 2017 / 8:17 PM / 4 months ago

BRIEF-FDA accepts Biomarin's Pegvaliase Biologics License Application

Aug 29 (Reuters) - Biomarin Pharmaceutical Inc

* FDA accepts Biomarin’s Pegvaliase Biologics License Application (bla) and grants priority review designation

* Biomarin Pharmaceutical Inc - ‍PDUFA action date is February 28, 2018​

* Biomarin Pharmaceutical Inc - ‍FDA has requested additional Chemistry, Manufacturing, and Controls (CMC) information for Pegvaliase​

* Biomarin - ‍When additional information is submitted to FDA, it will be classified as major amendment and result in 3 month extension of PDUFA date​

* Biomarin Pharmaceutical Inc - FDA has not informed company whether an advisory committee meeting to discuss pegvaliase​ application will be needed Source text for Eikon: Further company coverage:

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