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CagriSema FDA approval timeline Novo Nordisk submitted the New Drug Application (NDA) to the FDA on December 18, 2025 , for chronic weight management in adults with obesity or overweight with a weight-related comorbidity

1 Further, new data will complement the extensive body of cardiometabolic and kidney evidence for semaglutide in people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from additional real-world studies in adults with obesity

Any diluent selection, preparation, temperature, aliquoting, or post-reconstitution hold conditions must be established by a qualified laboratory under a validated SOP

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