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Intercept Drug Receives Unfavorable Votes From FDA Advisory Panel

Por: MarketWatch Business May 20, 2023

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The gastrointestinal drugs committee reviewed obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis. Intercept said it was disappointed with the outcome. We continue to disagree with the FDA on certain characterizations of OCA's efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests, the Morristown, N.J.-based company said. On the question given the available... + full article



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