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BioWorld - Thursday, April 16, 2026
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Home » No more hold for FOLD as FDA U-turn puts migalastat NDA into fast lane
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No more hold for FOLD as FDA U-turn puts migalastat NDA into fast lane

July 12, 2017
By Marie Powers
The FDA's green light for the submission of Amicus Therapeutics Inc.'s new drug application (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" within the same FDA review division who previously looked askance at the company's data package.
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