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Alexion Receives Notification of PDUFA Date Extension for Kanuma ...
2015-09-04 23:15:02| Biotech - Topix.net
Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act date for its Priority Review of the Company's Biologics License Application for Kanuma a , an investigational enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency . The previously disclosed September 8, 2015 PDUFA date has been extended by the standard extension period of three months.
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Category:Biotechnology and Pharmaceuticals