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.
Type 1 Diabetes
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 FreeStyle Libre 2 App to Monitor Glucose Levels
By scanning the glucose sensor with the app, users will be able to receive their current glucose level, trend arrow, and glucose history.
FDA Rejects Teplizumab BLA for 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 Panel Votes on Teplizumab for the Delay of Type 1 Diabetes
Teplizumab is an investigational anti-CD3 monoclonal antibody.
Pancreatic Islet Replacement Therapy Fast Tracked for Type 1 Diabetes
VX-880 is an investigational allogeneic human stem cell-derived islet cell therapy that may restore pancreatic islet cell function.
FDA Committee Votes on Oral T1D Treatment Sotagliflozin
The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.
Hypoglycemia Following Antifungal Tx in Patient With Type 1 Diabetes
“This is the first report of decreased insulin requirements in a patient with T1DM correlating with micafungin administration,” noted the authors.
Ready-to-Use Glucagon Rescue Pen Under FDA Review for Severe Hypoglycemia Tx
The NDA included findings from multiple Phase 3 trials evaluating the safety, efficacy, and utility of the Xeris glucagon rescue pen auto-injector to treat severe hypoglycemia vs currently available glucagon emergency kits in children, adolescents, and adults with type 1 diabetes.
Positive Results for Empagliflozin in Type 1 Diabetes Trials
The EASE Phase 3 program included 2 double-blind, placebo-controlled trials investigating the efficacy and safety of empagliflozin as an adjunct to insulin therapy in adults with type 1 diabetes.
