FDA Rejects NASH Drug for the Second Time
Last month, an FDA advisory committee voted to delay the approval until clinical outcome data became available.
Source: medscape.com
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US FDA declines to approve Intercept's fatty liver disease drug
(Reuters) - The U.S. Food and Drug Administration on Thursday declined to grant accelerated approval for Intercept Pharmaceuticals' drug to treat a ty...
Source: kelo.com
FDA declines to approve Intercept's fatty liver disease drug
FDA determined the marketing application for the drug cannot be approved in its present form
Source: dunyanews.tv
US FDA declines to approve Intercept's fatty liver disease drug
The rejection marks Intercept's second failed attempt at securing approval for the drug to treat patients with non-alcoholic steatohepatitis (NASH) - a liver disease that affects 5% of U.S. adults but has no approved treatments after numerous clinical failures by several drugmakers. Intercept was previously turned down by the FDA in 2020 as the agency determined the drug's predicted effectiveness failed to outweigh potential risks. Following the FDA's decision on Thursday, the company said it has decided to discontinue all NASH-related investment and restructure its operations...
Source: yahoo.com
US FDA declines to approve Intercept's fatty liver disease drug | WKZO | Everything Kalamazoo
(Reuters) - The U.S. Food and Drug Administration on Thursday declined to grant accelerated approval for Intercept Pharmaceuticals' drug to treat a ty...
Source: wkzo.com