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.
Diagnosis & Disease Information
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.
Hydrocortisone Rescue Pen Fast Tracked for Adrenal Insufficiency
ATRS-1902 is an investigational rescue treatment that uses a proprietary autoinjector to deliver a liquid stable formulation of hydrocortisone.
Packaging Update Announced for Rybelsus Tablets
The Company is transitioning away from the blister packs to fully recyclable 30-count bottles.
Recorlev Approved to Treat Endogenous Hypercortisolemia in Cushing Syndrome
The approval was based on data from two phase 3 studies that evaluated Recorlev in 166 adults with endogenous Cushing syndrome.
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