Novo Nordisk Seeks FDA Approval for “Super-Charged” Wegovy Dose; Review Expedited Under New Priority Program

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Novo Nordisk has officially filed for FDA approval of a higher, 7.2 mg dose of the weight-loss drug Wegovy®. Submitted under the expedited CNPV program, the new dose promises an accelerated review timeline. Phase 3 trial results indicate the 7.2 mg injection could offer significantly greater weight loss potential than the current standard dose.

Novo Nordisk Unveils Promising Phase 3 Data for Cagrilintide, a Novel Amylin Analogue for Obesity, Advancing to New Clinical Program

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Novo Nordisk has unveiled compelling phase 3 data for its next-generation obesity drug, cagrilintide, at the EASD 2025 congress. The novel amylin analogue demonstrated a significant 11.8% average body weight reduction over 68 weeks, far surpassing the placebo group. These promising results have prompted the company to advance cagrilintide into a new dedicated clinical program, RENEW, set to begin later this year.

Wegovy® Shows Superior Cardiovascular Protection Over Tirzepatide in Real-World Study

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The landmark STEER study provides the first head-to-head real-world comparison of the cardiovascular benefits of Wegovy® and tirzepatide. In a study of over 21,000 adults with obesity and established cardiovascular disease, Wegovy® (semaglutide 2.4 mg) demonstrated a significantly greater reduction in the risk of heart attack, stroke, and death compared to tirzepatide.