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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

First, it is indicated for chronic weight management in adults with obesity (BMI 30 kg/m) or overweight (BMI 27 kg/m) with at least one weight-related comorbidity, when used alongside a reduced-calorie diet and increased physical activity

The potential additive effect on glucose control is a real benefit, particularly for someone managing type 2 diabetes alongside weight loss goals

This means that it is safe for more people, especially those with high blood pressure, sleep issues, anxiety and more