Noninferiority of Once-Weekly Insulin Icodec Demonstrated in Two T2D Trials
The 26-week ONWARDS 3 and 4 clinical trials evaluated the efficacy and safety of insulin icodec in adults with type 2 diabetes.
Endocrine Disorders
Sotagliflozin Under Review for Heart Failure Treatment
Sotagliflozin is an investigational dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor.
Insulin Biosimilar Recalled Due to Missing Label on Prefilled Pens
The recalled product does not pertain to the branded interchangeable biosimilar, Semglee (insulin glargine-yfgn).
FDA Extends Review Period for Teplizumab for Type 1 Diabetes Delay
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
Aflibercept 16-Week Dosing Regimen for Diabetic Retinopathy Under Review
The sBLA is supported by data from the phase 3 PANORAMA trial and the NIH-sponsored Protocol W trial.
Dulaglutide Improves Glycemic Control in Youth With Uncontrolled T2D
Dulaglutide is a glucagon-like peptide-1 receptor agonist.
FDA Accepts Resubmitted Teplizumab BLA for T1D Delay
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
Hypoparathyroidism Effectively Managed With TransCon PTH in Phase 3 Trial
The phase 3 PaTHway trial included 82 adults with chronic hypoparathyroidism.
Provention Bio Resubmits BLA for Teplizumab to Delay Type 1 Diabetes
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
FDA Clears Omnipod 5 Tubeless Insulin System for Diabetes Management
The Omnipod 5 System consists of a tubeless wearable Pod, the Omnipod 5 mobile app, and the Dexcom G6 Continuous Glucose Monitoring System.
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