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.
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.
FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly
Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the risk of heart attacks and strokes.
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,
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,
Enobosarm demonstrated a statistically significant benefit in preserving lean mass in patients with overweight or obesity undergoing treatment with semaglutide.Topline results from the Phase
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 FDA has approved popular antiobesity drug Ozempic to help protect patients with type 2 diabetes from kidney disease.
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.
The US Food and Drug Administration (FDA) approval is based on the clinical trials that showed how Ozempic, the diabetes drug, showed a reduced risk of kidney failure. Experts explain how the drug helps.