Amicus wanted to fast-track a Pompe disease approval filing. The FDA said no
The FDA has rejected Amicus Therapeutics' request to fast-track a filing for its therapy for Pompe disease.
by Adam Feuerstein
Sep 10, 2018
1 minute
The Food and Drug Administration told Amicus Therapeutics () that it lacks sufficient clinical data on an experimental treatment for Pompe disease to submit a marketing application, the company said Monday.
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