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Nov 26, 2025 4:00 PM

Novo Nordisk Wants FDA Nod For A Higher-Dose Wegovy

On Wednesday, Novo Nordisk A/S (NYSE:NVO) submitted its supplemental marketing application to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg for chronic weight management.

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The new, higher dose of Wegovy (semaglutide 7.2 mg) is currently under review with the European Medicines Agency, in the U.K., and several other countries.

In the EU, Novo Nordisk expects a regulatory decision in Q1 2026.

Under the Commissioner's National Priority Voucher (CNPV) expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing.

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