FDA Extends Review of Novo Nordisk Drug
The US FDA has delayed its decision on Novo Nordisk's experimental hemophilia A drug to address manufacturing facility issues. The regulator raised no safety concerns, and the company still aims for a 2027 US launch.
Insights:
The United States Food and Drug Administration extended its review of Novo Nordisk's experimental hemophilia A drug over manufacturing site remediation issues, the Denmark-based drugmaker said on Friday. The delay impacts the application for denecimig, which targets adults and children with the rare blood-clotting disorder. The setback arrives as the company preserves its financial forecasts for 2026 while targeting a commercial launch in the first half of 2027.
