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Novo Nordisk presented the phase 3 monotherapy results in September 2025 and submitted an NDA for CagriSema to the FDA on 18 December 2025, based on REDEFINE 1 and REDEFINE 2

0169) edqm.eu FDA, Drug Safety Communication: Benzyl alcohol toxicity in neonates fda.gov Centers for Disease Control and Prevention, Safe Injection Practices cdc.gov This article is for general information only and is not medical advice