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July 29, 2021
The approval allows for substitution at the pharmacy counter for Lantus, its reference product.
July 25, 2021
Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
July 18, 2021
FDA staff raised safety concerns ahead of the advisory panel hearing.
June 21, 2021
A longstanding four times per day testing requirement will cease, and patients using inhaled insulin now qualify for continuous glucose monitoring.
June 07, 2021
Semaglutide injection is a weekly injection for chronic weight management in adults.
May 04, 2021
The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.
February 22, 2021
Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.
January 13, 2021
AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.
June 02, 2020
Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.
September 24, 2019
How the first oral GLP-1 oral treatment for type 2 diabetes is unique and how it will be priced compared to other GLP-1 medications.
