Intercept Pharma’s obeticholic acid (OCA) – trying to become the first FDA-approved therapy for non-alcoholic steatohepatitis (NASH) – will come under scrutiny by FDA advisors before the ...
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FDA approves Madrigal’s Rezdiffra as the first NASH therapyThe latest in this line of disappointments was the US FDA rejection of Intercept Pharmaceuticals’ new drug application (NDA) for its NASH therapy, obeticholic acid. The agency cited concerns ...
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Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europe ...
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