Novo Nordisk says FDA review of denecimig BLA for haemophilia A still ongoing, no new action timeline given

Novo Nordisk says the FDA has informed it that the Biologics License Application review for denecimig, its treatment for haemophilia A, remains ongoing and no new timeline for regulatory action has been communicated. The delay is attributed to ongoing facility remediation activities.

Detected & updated continuously · Source: Nebula