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Unfavorable benefit-risk : FDA panel votes against obeticholic acid approval for NASH

An FDA advisory committee voted against approval for obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis, citing “concerning” risk/benefit profile.

Intercept Pharma (ICPT) Reports Efficacy and Safety Data from Phase 3 REGENERATE Study

Intercept Pharma (ICPT) Reports Efficacy and Safety Data from Phase 3 REGENERATE Study
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