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

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

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

Part of story

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

Other sources for this story

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

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

Part of story

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

Other sources for this story

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