The FDA is taking more time to decide on Novo Nordisk's hemophilia drug.

Oct 5, 2026, 11:53 AM ETRulesRead the original at Benzinga

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Novo Nordisk must complete factory repairs, and the FDA has not set a new decision date. No safety or trial-data problems were found, but the delay puts the planned U.S. launch timing at risk.

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The delay puts Novo Nordisk’s planned U.S. launch in the first half of 2027 at risk, and the FDA has not set a new decision date. The agency found no problems with safety or clinical trial data, and other products are unaffected. Factory repairs are still needed.

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