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Intercept Pharmaceuticals Inc (ICPT)

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US FDA says Intercept's drug can cause liver injury in patients without scarring

US FDA says Intercept's drug can cause liver injury in patients without scarring

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.

Reuters | 1 year ago
US FDA declines full approval for Intercept's liver disease drug

US FDA declines full approval for Intercept's liver disease drug

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.

Reuters | 1 year ago
FDA advisers vote against confirmatory data for Intercept's liver disease drug

FDA advisers vote against confirmatory data for Intercept's liver disease drug

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.

Reuters | 1 year ago
FDA staff raises efficacy concerns over Intercept's liver disease drug

FDA staff raises efficacy concerns over Intercept's liver disease drug

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.

Reuters | 1 year ago