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FDA Rejects Full Approval of Liver Disease Drug

Source link : https://www.newshealth.biz/health-news/fda-rejects-full-approval-of-liver-disease-drug/

The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary biliary cholangitis (PBC), Intercept Pharmaceuticals announced on Tuesday. The decision follows a September meeting of the agency’s Gastrointestinal Drugs Advisory Committee, which agreed that the farnesoid X receptor (FXR) agonist did not have a favorable benefit-risk profile as a second-line agent […]

Author : News Health

Publish date : 2024-11-12 21:40:31

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