FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

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FDA delays Novo Nordisk's denecimig hemophilia A drug review over manufacturing issues

The FDA has extended its review of Novo Nordisk's hemophilia A injection denecimig (brand name Frehemgo) due to issues at an unidentified manufacturing facility. The agency has not provided a new timeline for the regulatory decision on the biologics license application.

Oct 5, 20265 sources

FDA delays Novo Nordisk's denecimig hemophilia A drug review over manufacturing issues

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Biospace

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

Fiercepharma

Novo flags FDA hemophilia review extension tied to manufacturing site corrections

Endpoints

FDA delays Novo’s hemophilia A drug review over factory issues

Statnews

FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

Part of story

FDA delays Novo Nordisk's denecimig hemophilia A drug review over manufacturing issues

Other sources for this story

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

Novo flags FDA hemophilia review extension tied to manufacturing site corrections

FDA delays Novo’s hemophilia A drug review over factory issues

Pharmalittle: We're reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more

FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

Part of story

FDA delays Novo Nordisk's denecimig hemophilia A drug review over manufacturing issues

Other sources for this story

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

Novo flags FDA hemophilia review extension tied to manufacturing site corrections

FDA delays Novo’s hemophilia A drug review over factory issues

Pharmalittle: We're reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more