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FDA Reverses Decision, Allowing Amicus To File For Rare Disease Drug

FDA Reverses Decision, Allowing Amicus To File For Rare Disease Drug

Last November, tiny Amicus Therapeutics said that the Food and Drug Administration would not even consider approving migalastat, a treatment for a rare disorder called Fabry disease, until more data were collected, a process that was expected to take until 2019 or 2020.

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