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Semaglutide News (Page 8)
FDA Medwatch Alert: Drug Safety Communication: Certain Type of Medicines Approved for Type 2 Diabetes and Obesity - Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 RAs; see the list in...
FDA Medwatch Alert: FDA Issues Warning About Compounded Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss
On May 30, 2023, the FDA posted information about medications containing semaglutide marketed for type 2 diabetes or weight loss. There are currently three FDA-approved semaglutide products which are...
Novo Nordisk Announces FDA Approval of Label Update for Rybelsus (semaglutide) Allowing Use as a First-Line Option for Adults with Type 2 Diabetes
People living with type 2 diabetes can now take Rybelsus®, the first and only oral glucagon-like peptide-1 (GLP-1) analog, along with diet and exercise, as initial therapy to help lower their A1C1,2 ...
FDA Approves Once-Weekly Wegovy injection for the Treatment of Obesity in Teens Aged 12 Years and Older
New indication based on clinical trial that demonstrated a 16.1% reduction in body mass index (BMI) in teens with obesity treated with Wegovy® (semaglutide) injection 2.4 mg compared to placebo ...
Novo Nordisk Receives FDA Approval of Higher-Dose Ozempic 2 mg Providing Increased Glycemic Control for Adults with Type 2 Diabetes
Ozempic® demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes with new 2 mg dose1 PLAINSBORO, N.J., March 28, 2022 /PRNewswire/ – Novo Nordisk today ...
FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity
PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injec...
FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease
PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide) injection 0.5 mg...
FDA Approves Rybelsus (semaglutide), the First Oral GLP-1 Analog Treatment for Adults with Type 2 Diabetes
PLAINSBORO, N.J., Sept. 20, 2019 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults...
Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
December 5, 2017 – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a...
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Weight Loss (Obesity / Overweight), Cardiovascular Risk Reduction, Chronic Kidney Disease, Diabetes, Type 2