PLAINSBORO, N.J., Jan. 28, 2025 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic ® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD ...

The FDA approved a new use for a drug to reduce the risk of cardiovascular disease, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.

Oct 31, 2024 · Earlier this year, the FDA issued a Form 483 (PDF) rebuke to Novo Nordisk following an inspection of the company’s production site in Kalundborg, Denmark. Novo uses the site to make its hit...

1 day ago · Eli Lilly & Co. and Novo Nordisk A/S are asking a federal court to reject legal protections to drug compounders making copycat versions of the weight loss drug tirzepatide. The two drugmakers moved Tuesday in the legal battle between the Food and Drug Administration and drug compounders over whether the the FDA lawfully determined that Lilly’s tirzepatide—a diabetes and obesity treatment ...

Jan 28, 2025 · The Food and Drug Administration approved Novo Nordisk's Ozempic for patients with both chronic kidney disease and diabetes, expanding the use of the wildly popular injection in the U.S.

PLAINSBORO, N.J., Dec. 20, 2024 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) approved Alhemo ® (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with ...

this document lists observations made by the fda representative(s) during the inspection of your facility. THEY ARE INSPECTIONAL OBSERVATIONS; AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION ...

3 days ago · Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US.

May 24, 2024 · co-I Insulin Icodec: Once-Weekly Basal Insulin for Treatment of Adults with Diabetes Mellitus Novo Nordisk Endocrinologic and Metabolic Drugs Advisory Committee May 24, 2024 . co-2 Introduction...

Jan 29, 2025 · The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks associated with chronic kidney disease (CKD). The Danish drugmaker’s popular weight loss medication is now indicated to reduce the risk of kidney failure and disease progression, as well as death due to cardiovascular disease.