September 11, 2024 02:48 PM EDT

FDA is poised to pull Ocaliva as adcomm documents question post-approval study results

Max Gelman

Senior Editor

The FDA appeared ready to pull its accelerated approval of Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva, bluntly laying out its rationale in …

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FDA is poised to pull Ocaliva as adcomm documents question post-approval study results

Max Gelman

Senior Editor

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FDA is poised to pull Ocali­va as ad­comm doc­u­ments ques­tion post-ap­proval study re­sults

Senior Editor

Sign up to read this article for free.

Viridian Therapeutics

Waltham, MA, USA

FDA is poised to pull Ocaliva as adcomm documents question post-approval study results