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Ocaliva’s Takedown by FDA Panel

Source link : https://www.newshealth.biz/health-news/ocalivas-takedown-by-fda-panel/

Without sufficient data to work with, FDA advisors were strongly inclined against giving full approval of obeticholic acid (Ocaliva or OCA) in primary biliary cholangitis (PBC). On Friday, the agency’s Gastrointestinal Drugs Advisory Committee members voted 10-1 (with three abstentions) that the farnesoid X receptor agonist did not have a favorable benefit-risk profile when used […]

Author : News Health

Publish date : 2024-09-13 21:34:31

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