News details - novonordisk-us.com
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 ...
FDA approves new indication for Novo Nordisk’s Ozempic
20 hours ago · Novo Nordisk has received the Food and Drug Administration’s permission for Ozempic to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease) and death due to ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic …
Jan 28, 2025 · The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney ...
Novo Nordisk secures FDA approval for Ozempic in diabetes with …
Jan 29, 2025 · Novo Nordisk said its drug is the “most broadly indicated” GLP-1RA in its class. Novo Nordisk’s clinical development, medical and regulatory affairs senior vice president Anna Windle said: “This approval for Ozempic allows us to more broadly address conditions within the cardiovascular-kidney-metabolic syndrome, which affects millions ...
FDA Approves First Treatment to Reduce Risk of Serious Heart …
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.
FDA approves Novo Nordisk's Ozempic to treat chronic kidney …
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.
FDA rebukes Novo Nordisk on production, permission issues …
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...
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 ...
News Details - Novo Nordisk
Bagsværd, Denmark, 10 July 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus.
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...