Intercept Pharmaceuticals' liver disease drug can cause injury to the organ in patients without severe scarring, the U.S. Food and Drug Administration said on Thursday, based on its review of postmarket clinical trial data.
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market.
Independent advisers to the U.S. Food and Drug Administration voted on Friday against confirmatory trial data for Intercept Pharmaceuticals' liver disease drug, putting into question the treatment's future in the U.S. market.
The U.S. Food and Drug Administration's staff on Wednesday raised concerns over the efficacy of Intercept Pharmaceuticals' liver disease drug, which is awaiting the regulator's traditional approval.