India, Oct. 3 -- Novo Nordisk A/S (NVO), a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) informed the company that its Biologics License Application (BLA) review of denecimig for haemophilia A treatment remains ongoing, with no new regulatory timeline communicated.
The FDA cited ongoing facility remediation activities are the cause for the extended review period. However, the agency has not identified any deficiencies related to the clinical efficacy or safety data submitted with the denecimig BLA.
Novo Nordisk submitted the denecimig BLA in September 2025 with an anticipated regulatory decision in the third quarter of 2026. Following the submission, the FDA conducted a pre-license inspection of the ma...