-
Diabetes and Metabolic Disorders: The Approval of Teplizumab
David Orchard-Webb
June 23, 2025
Teplizumab, the first disease-modifying therapy for Type 1 diabetes, delays disease onset by ~4 years in high-risk individuals. Priced at $194,000 per course, it redefines early intervention despite cost barriers.
-
FDA Approves Automated Insulin Delivery, Monitoring System for Young Pediatric Patients
americanpharmaceuticalreview
September 02, 2020
The U.S. Food and Drug Administration (FDA) approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input ...
-
Artificial pancreas for type 1 diabetes control given nod by FDA
europeanpharmaceuticalreview
August 28, 2020
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
-
Research links COVID-19 to rise in childhood type 1 diabetes
expresspharma
August 24, 2020
This study analysed data from 30 children in London hospitals diagnosed with new-onset type 1 diabetes during the first peak of the pandemic.
-
Provention Bio Initiates Rolling Submission of BLA for Teplizumab for Type 1 Diabetes
americanpharmaceuticalreview
April 17, 2020
Provention Bio announced the initiation of the rolling submission of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031).
-
FDA hands Boehringer and Lilly complete response letter for insulin adjunct
March 26, 2020
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
-
Boehringer, Lilly Get Complete Response Letter for Empagliflozin
contractpharma
March 24, 2020
FDA is unable to approve sNDA for Empagliflozin in type 1 diabetes.
-
Provention Bio Provides Pauses Type 1 Diabetes Treatment Study
americanpharmaceuticalreview
March 20, 2020
Provention Bio announced a temporary pause in the randomization of patients with newly diagnosed type 1 diabetes (T1D) into its global Phase 3 PROTECT study of PRV-031 (teplizumab).
-
Severe Hypoglycemia in Seniors With T1DM May Worsen Cognition
drugs
January 06, 2020
Both recent severe hypoglycemia (SH) and lifetime SH are associated with worse cognition among older adults with type 1 diabetes, according to a study published online December in Diabetes Care.
-
Big Advances Made Against Diabetes in 2019
drugs
January 02, 2020
A new artificial pancreas system, drugs that help control blood sugar and protect the heart and the kidneys, a new medication that delays type 1 diabetes ...