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FDA News
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.
TLANDO, an Oral Option for TRT for Men, Approved by US FDA
March 29, 2022
On March 29, Antares Pharma announced the FDA granted approval to their oral testosterone replacement therapy option, testosterone udecanoate (TLANDO), for conditions associated with a deficiency or absence of endogenous testosterone or hypogonadism in adult males.
FDA Approves 2.0 mg Dose of Semaglutide
March 29, 2022
On March 28, Novo Nordisk announced the US FDA had granted approval to their 2.0 mg dose of semaglutide (Ozempic) as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes and to reduce the risk of major cardiovascular events in adults with type 2 diabetes and history of CVD.
FDA Grants Dexcom CGM Breakthrough Designation for In-Hospital Use
March 02, 2022
Announced on March 1, the Breakthrough Device Designation from the FDA allows for use of Dexcom CGM technology in in-hospital settings and at other healthcare facilities.
Bardoxolone Rejected by FDA for CKD Caused by Alport Syndrome
February 26, 2022
Announced by Reata Pharmaceuticals on February 25, the Complete Response Letter from the FDA for bardoxolone methyl comes a little over 2 months after an FDA advisory committee voted unanimously against approval of the once-daily, orally administered activator of Nrf2.
Tandem Diabetes Receives FDA Clearance for t:connect mobile app
February 21, 2022
Announced on Feb. 18, the t:connect mobile app, which pairs with the t:slim X2 insulin pump, is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems, according to Tandem Diabetes Care.
US FDA Approves Eversense E3 CGM System, Allows Use for Up to 6 Months
February 11, 2022
Announced on February 11, the approval for Eversense E3 continuous glucose monitoring system allows access to a CGM system with 6 months of longevity and is expected to be available beginning in the second quarter of 2022.
Faricimab Receives Approval from US FDA for Diabetic Macular Edema, Wet AMD
January 31, 2022
Announced on Jan. 31, the approved indication is a first-of-its-kind for a novel therapy—a bispecific antibody injection treatment for the leading causes of blindness.
FDA Approves Omnipod 5 Automated Insulin Delivery System for Type 1 Diabetes in Ages 6 and Older
January 28, 2022
Announced on Jan. 28, the Omnipod 5 AID becomes the first tubeless automated insulin delivery system with the ability to integrate with the Dexcom G6 continuous glucose Monitoring System and a compatible smartphone to automatically adjust insulin and protect against glycemic events