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At least five PDUFA dates on deck in October
One decision on a new drug from Amicus, plus three supplement applications and a drug-device combo
September 30, 2022 10:59 PM UTC
At least five therapies have PDUFA dates in October. The decision on Amicus’ BLA could be accompanied by an overdue decision on the NDA for the therapy’s second component.
Amicus Therapeutics Inc. (NASDAQ:FOLD) had a PDUFA goal date in August for an NDA covering the miglustat component of its candidate Pompe disease therapy AT-GAA. A decision on the application has not been announced and may come in conjunction with a decision on a BLA covering the therapy’s second component, cipaglucosidase alfa. The goal date for that application in Oct. 29. ...