FDA extends review of Novo Nordisk hemophilia drug over manufacturing issues

The FDA has extended its review of Novo Nordisk’s denecimig, an investigational treatment for hemophilia A, because remediation work is continuing at a manufacturing facility. The agency has not provided a new date for a decision after Novo’s expected third-quarter 2026 review window passed. Novo said the FDA has identified no concerns with the drug’s clinical safety or efficacy data and that it is addressing the agency’s manufacturing-related feedback. The company is still aiming for a U.S. launch in the first half of 2027.