US FDA extends review of Novo Nordisk’s hemophilia drug over facility issues

US FDA extends review of Novo Nordisk’s hemophilia drug over facility issues - Regional Media News

Oct 2 (Reuters) - The US FDA has extended its review of Novo Nordisk's experimental hemophilia A drug due to ongoing remediation work at a manufacturing facility, the Danish drugmaker said on Friday. Here are some details: • The company was seeking the US Food [...]

US FDA extends review of Novo Nordisk’s hemophilia drug over facility issues

Oct 2 (Reuters) - The US FDA has extended its review of Novo Nordisk's experimental hemophilia A drug due to ongoing ​remediation work at a manufacturing facility, ‌the Danish drugmaker said on Friday. Here are some details: • The company was seeking t...

FDA extends review for Novo Nordisk's denecimig for hemophilia A

FDA delays Novo Nordisk’s denecimig hemophilia A approval as facility remediation extends BLA review. Read more here.

Novo Nordisk A/S says FDA extends denecimig review

Novo Nordisk says facility remediation extended the FDA's denecimig review beyond Q3 2026, with no new action date yet.

Novo provides update on the denecimig Biologics License Application (BLA) in the US