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FDA News

 

FDA Updates Finerenone Label to Reflect Cardiovascular Outcomes Data

September 08, 2022

On September 1, Bayer announced the US FDA had approved a label update for finerenone (Kerendia), which received initial approval in July 2021 for chronic kidney disease associated with type 2 diabetes, to include cardiovascular outcomes data from the FIGARO-DKD trial.

Endocrine Month in Review: August 2022

August 27, 2022

Our endocrinology month in review spotlights the most popular content from the past month. Our top content from August 2022 includes a trial examining time-restricted eating, a pair of FDA decisions, coverage of ADCES 22, and more!

MYFEMBREE Scores FDA Approval for Endometriosis Pain

August 06, 2022

On August 5, Pfizer announced the FDA's approval of relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg (MYFEMBREE) for the management of moderate to severe pain associated with endometriosis in premenopausal women for up to 24 months.

Endocrine Month in Review: July 2022

July 30, 2022

Our endocrinology month in review spotlights the most popular content from the past month. The top content from July includes hormone therapy guidance from NAMS, a comparison of management practices among Medicare beneficiaries, and a recap of the top approvals from the first half of 2022.

Top FDA Approvals in Diabetes Care from the First Half of 2022

July 01, 2022

With the first 6 months of 2022 behind us, Endocrinology Network has compiled a list of the top approvals in diabetes care from the first half of the year. The list includes multiple approvals for CGM, a first-in-class agent, and an increased dose of a popular GLP-1 RA.

FreeStyle Libre 3 Receives FDA Clearance for Diabetes in Patients 4 Years and Older

May 31, 2022

The FreeStyle Libre 3 system, which is billed by Abbott as the world's smallest, thinnest, and most accurate 14-day glucose sensor, received FDA clearance on May 31 and is expected to be available in participating pharmacies later this year.

Endocrine Month in Review: May 2022

May 28, 2022

Our endocrine month in review spotlights the most popular articles from the past month. This month's top articles include the approval of tirzepatide, news from AACE & ATTD, and a pair of podcast episodes.

Diabetes Dialogue: Tirzepatide in Action & AACE 2022 Recap

May 20, 2022

In this episode of Diabetes Dialogue, hosts Drs. Isaacs and Bellini take a deep dive into the tirzepatide approval, including discussions around the mechanism of action, dose titrations, and where it might fit in the upcoming ADA standards of care. Later in the episode, hosts recap their experiences from AACE 2022, which saw the release of new guidelines for NAFLD.

Tirzepatide (Mounjaro) Wins FDA Approval for Type 2 Diabetes

May 13, 2022

Announced on May 13, the approval indicates Eli Lilly and Company's novel dual GLP-1/GIP agonist, tirzepatide (Mounjaro), for use as an adjunct to diet and exercise to improve blood sugar in adult patients with type 2 diabetes.