XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. The approved drugs contain the base form of semaglutide.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

Insulin 52

Insulin FDA Approval Doctors Doctor 52

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

FDA Law Blog

FEBRUARY 7, 2022

The post contained a video entitled 10,080 Minutes that “prominently communicates that Trulicity can help ‘lower A1C along with diet and exercise,’” but “fails to adequately communicate Trulicity’s FDA-approved indication and the limitations of use” thereby creating a “misleading impression about the scope of the FDA-approved indication.”

Insulin 40

Insulin FDA Approval Drugs Production 40

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

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Sales Manufacturing FDA Approval Life Science 98