Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…

ByRidhi RastogiNovember 27, 2025

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Novo Nordisk Reports STEER Real-World Study Data on Wegovy for Obesity and Cardiovascular Disease

Shots: The STEER real-world study data assessed the risk of major adverse cardiovascular events (MACE) with Wegovy (semaglutide 2.4mg) vs tirzepatide among overweight or obese pts with CVD, but no diabetes in the US Study showed that continuous treatment (>30 days no gap) with Wegovy reduced risk of heart attack, stroke, CV or all-cause death…

ByRidhi RastogiSeptember 2, 2025

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Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively Approval was based on Part…

ByRidhi RastogiAugust 18, 2025

NEWS

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

Shots: The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…

ByRidhi RastogiJuly 9, 2025

NEWS

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots: The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25) Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 2025

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Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Novo Nordisk Reports STEER Real-World Study Data on Wegovy for Obesity and Cardiovascular Disease

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Top 20 Biopharma Companies of 2025

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