Semaglutide
United Kingdom
MHRA approves semaglutide (Wegovy) to reduce the risk of serious heart problems
Wegovy (once-weekly injection) · Cardiovascular risk reduction
MHRA announced approval of semaglutide to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and a BMI of 27 or more.
Why it matters: The UK decision came four and a half months after the US one and is a separate regulatory event with its own wording; approval is not NHS funding.
Source: MHRA, 23 Jul 2024
Last checked 13 Sep 2026 · Report a correction
United States
FDA approves Ozempic (semaglutide) for type 2 diabetes
Ozempic (once-weekly injection) · Type 2 diabetes (glycaemic control)
Original approval of NDA 209637 on 5 December 2017 to improve glycaemic control in adults with type 2 diabetes.
Why it matters: Weight loss seen in Ozempic's diabetes trials is not a weight-management indication; that came with Wegovy in 2021.
Source: US Food and Drug Administration (Drugs@FDA)
Last checked 13 Sep 2026 · Report a correction
FDA approves Rybelsus (oral semaglutide) for type 2 diabetes
Rybelsus (once-daily tablet) · Type 2 diabetes (glycaemic control)
Original approval of NDA 213051 on 20 September 2019, the first oral GLP-1 receptor agonist, for glycaemic control in adults with type 2 diabetes.
Why it matters: A different formulation of the same molecule with its own application and label; oral semaglutide for weight management is a separate product.
Source: US Food and Drug Administration (Drugs@FDA)
Last checked 13 Sep 2026 · Report a correction
FDA approves Wegovy (semaglutide 2.4 mg) for chronic weight management
Wegovy (once-weekly injection) · Chronic weight management
Original approval of NDA 215256 on 4 June 2021 for chronic weight management in adults with obesity, or overweight with at least one weight-related condition.
Why it matters: The first once-weekly GLP-1 medicine approved for weight management in the US; the workbook's 'June 2021' is confirmed to the day by the Drugs@FDA record.
Source: US Food and Drug Administration (Drugs@FDA)
Last checked 13 Sep 2026 · Report a correction
FDA adds cardiovascular risk reduction to Wegovy's indications
Wegovy (once-weekly injection) · Cardiovascular risk reduction
FDA approved an additional indication for Wegovy (semaglutide) injection: reducing the risk of cardiovascular death, heart attack and stroke in adults with established cardiovascular disease and either obesity or overweight, alongside a reduced-calorie diet and increased physical activity.
Why it matters: An additional use of an existing molecule, not a new medicine. It is the first weight-management medicine with a cardiovascular outcome indication in the US.
Source: US Food and Drug Administration, 8 Mar 2024
Last checked 13 Sep 2026 · Report a correction
European Union
CHMP recommends adding SELECT cardiovascular study information to Wegovy's product information
Wegovy (once-weekly injection) · Cardiovascular risk reduction
At its July 2024 meeting the CHMP recommended an update to Wegovy's product information to reflect the SELECT cardiovascular outcomes data. It did not recommend a separate cardiovascular-prevention indication.
Why it matters: The same scientific story produced different regional outcomes: a new indication in the US and UK, a product-information update in the EU. Regional labels must be read separately.
Source: European Medicines Agency, 26 Jul 2024
Last checked 13 Sep 2026 · Report a correction