Novo Says FDA Extends Denecimig BLA Review Over Facility Remediation
Novo Nordisk said in a company announcement on 2 October 2026 that the US Food and Drug Administration has extended its review of the Biologics License Application (BLA) for denecimig for the treatment of haemophilia A, with the agency citing ongoing remediation activities at the manufacturing facility as the cause. The FDA has not communicated a new timeline for regulatory action on the application, and Novo said the additional review time has no impact on its financial outlook for 2026. The…