Intercept's Ocaliva Seems Headed For Black Box On Liver Injury Risk
Executive Summary
Physician education on dosing also likely as firm hopes to show that serious adverse events in patients with less-advanced primary biliary cholangitis may not be related to the drug.
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CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.
Intercept’s NASH Drug Delayed By April Advisory Committee, But Firm Is Ready For Launch
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