TransCon PTH Gets Priority Review for Hypoparathyroidism
TransCon PTH is an investigational once-daily long-acting prodrug of parathyroid hormone (PTH[1-34]) designed to restore physiologic levels of PTH for 24 hours each day.
Endocrine Disorders
Presence of Glass Particles Prompts Recall of Octreotide Acetate Injection
To date, the Company has not received any reports of adverse reactions related to this recall.
NIH Study Compares Four Commonly Used Type 2 Diabetes Medications
The multicenter, randomized, controlled GRADE study was designed to compare the effectiveness of 4 major FDA-approved medications.
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.
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.
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