The latest semaglutide (Ozempic; Novo Nordisk) approval is set to tackle a major need for patients with both type 2 diabetes (T2D) and chronic kidney disease (CKD), addressing their cardiovascular (CV) and kidney disease risks.
Ozempic becomes the first GLP-1 treatment option for people with type 2 diabetes and chronic kidney disease The Food and Drug Administration has approved Ozempic to reduce the risk of kidney disease.
The US Food and Drug Administration on Tuesday approved Ozempic for adults with type 2 diabetes and chronic kidney disease (CKD). The drug is now indicated specifically to treat kidney failure, prevent death from cardiovascular disease,
Hims & Hers may leverage FDA compounding exemptions to further extend its compounded GLP-1 offerings. Learn why HIMS stock is a Hold.
FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, which registered as an outsourcing drug compounder in April 2022,
Wegovy is a GLP-1 agonist containing semaglutide, the same active ingredient as Ozempic. While both medications share this ingredient, they are approved for different purposes. Ozempic is primarily used for managing type 2 diabetes, whereas Wegovy is specifically approved for weight loss.
People who stayed on a 7.2 milligram weekly dose of semaglutide lost around 20% of their body weight over 72 weeks.
Lots of people are on cheaper compounded weight-loss drugs that mimic brands like Ozempic, Wegovy, and Zepbound. They're about to lose access.
The problem is, that's a temporary fix, too. While semaglutide is still on the shortage list, the FDA is expected to eventually end that designation, and compounders will have to stop making it ...
The approval is based on results from the Phase III FLOW trial demonstrating Ozempic reduced the risk of severe kidney outcomes by 24% compared to placebo, including kidney failure, reduction in kidney function, or death from kidney or heart causes, in diabetic patients with chronic kidney disease.