STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval
The Food and Drug Administration has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker, the biotech company UniQure, to file for U.S. approval, the company said Wednesday. UniQure will submit a marketing application in the third quarter seeking accelerated approval for the treatment, called AMT-130. The decision comes after a recent meeting with FDA officials during which the agency agreed that a three-year analysis of an...
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