FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes. To win the new indication, the…

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity.  The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’…

Signs are growing that the diabetes drug Ozempic (semaglutide) from Novo Nordisk can support weight loss in overweight and obese individuals. A recent JAMA study involving overweight and obese individuals gave recipients a 2.4-mg subcutaneous dose of semaglutide once weekly for 20 weeks. After that period, investigators continued administering the drug to half of the participants while…

Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide). The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021. The letter indicates that…

The diabetes drug Ozempic (semaglutide) could potentially enhance weight loss in overweight and obese patients without diabetes, according to a study recently published in JAMA and The New England Journal of Medicine. In December, Novo Nordisk (NYSE:NVO) submitted a new drug application to the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The drug won FDA…