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Novo provides update on the denecimig Biologics License Application (BLA) in the US
GlobeNewswire Inc.·
The FDA has extended its review of Novo Nordisk's denecimig BLA for haemophilia A treatment due to ongoing manufacturing facility remediation activities. No deficiencies were identified in clinical efficacy or safety data. Novo aims to launch denecimig in the US in H1 2027, pending regulatory approval. The delay does not impact Novo's 2026 financial outlook.
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