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No more hold for FOLD as FDA U-turn puts migalastat NDA into fast lane

By Marie Powers
News Editor

Tuesday, July 11, 2017

The FDA's green light for the submission of Amicus Therapeutics Inc.'s NDA for migalastat in Fabry disease followed what John Crowley, chairman and CEO, called a "data-driven, science-based discussion" with "largely the same reviewers."

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