FDA orders a rare retreat on Amicus’ migalastat, dropping PhIII demand and signaling a major shift for drug developers
Megan Crowley is recognized by President Donald Trump during his first address to a joint session of Congress on February 28, 2017. At 15 months old, Crowley was diagnosed with Pompe Disease and not expected to live more than a few short years. AP Images
Amicus Therapeutics $FOLD announced early Tuesday that the FDA has dropped its demand for a new Phase III study of its Fabry disease drug migalastat after it was stiff-armed by unsatisfied regulators last fall — then under a different administration with a different FDA commissioner.
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