STAT Plus: As approval decision nears, fate of Intercept’s NASH drug clouded by murky FDA review delays
On Friday, the Food and Drug Administration is supposed to announce its decision on whether or not to approve the first treatment for the fatty liver disease known as NASH. But that plan has apparently been postponed for reasons that are still not clear. The FDA hasn’t offered an explanation, nor has Intercept Pharmaceuticals, the maker of the NASH drug under review.
Reached on Monday, an Intercept spokesperson said the company intends to provide an update on “any material developments with respect to its regulatory timeline,” but has nothing to disclose at this time.
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