US FDA’s Opaque Galafold Review: A Rare Misstep In The Trump Era
When FDA reversed course and allowed Amicus to file for Accelerated Approval of migalastat, plenty of people suspected politics were at play. The agency's handling of the review won’t do anything to allay those suspicions.
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There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.
The latest drug development news and highlights from our US FDA Performance Tracker.
Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study. Additional information includes European submission data and post-launch RWE.