Covis Plans Makena Withdrawal, But Raises Accelerated Approval Questions

By Beth Wang / March 8, 2023 at 5:02 PM
Covis Pharma on Tuesday (March 7) announced it will withdraw its controversial preterm birth drug Makena from the market in line with calls from FDA and the agency’s advisers -- but the company also appeared to make a last-ditch effort to defend the drug’s efficacy and urge FDA to exercise regulatory flexibility to keep the drug on the market pending further clinical trials, as is allowed under the accelerated approval pathway. At the very least, if FDA and Covis do...

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