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Dec 18, 2025 4:00 PM

Novo Nordisk Files FDA Application For Weekly Combination Obesity Shot

Novo Nordisk A/S (NYSE:NVO) on Thursday submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema.

The application covers CagriSema for use with a reduced-calorie diet and increased physical activity to treat obesity or overweight in the presence of at least one weight-related comorbid condition.

CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg, and the GLP-1 receptor agonist, semaglutide 2.4 mg.2 If approved, CagriSema would become the first injectable GLP-1 receptor agonist and amylin analogue combination treatment.

The application is based on ...