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FDA Grants Breakthrough Therapy Designation to Provention Bio’s Teplizumab for Prevention or Delay of Type 1 Diabetes in At-Risk Individuals

OLDWICK, N.J., Aug. 5, 2019 /PRNewswire/ — Provention Bio, Inc. (Nasdaq:PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type …

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FDA Approves Lilly’s Baqsimi, the First Treatment for Severe Hyperglycemia That Can Be Administered Without An Injection

INDIANAPOLIS, July 24, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved BAQSIMI™ (glucagon) nasal powder 3 mg for the treatment of severe hypoglycemia in people with diabetes ages four years and above, Eli Lilly and Company (NYSE: LLY) announced today. BAQSIMI is the first and only nasally administered glucagon, and it …

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Baxter Announces FDA Approval of Myxredlin, the First and Only Ready-to-Use Insulin for IV Infusion

DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA) approval of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection). Myxredlin (pronounced mix-RED-lin) is the first and only ready-to-use insulin for IV infusion in the hospital and other acute care …

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FDA Approves Novo Nordisk’s Victoza for Treatment of Type 2 Diabetes in Patients Aged 10-17 Years

PLAINSBORO, N.J., June 17, 2019 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza® (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes. As the first glucagon-like peptide-1 (GLP-1) receptor …

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Farxiga Study Showed Reduced Progression of Kidney Disease or Renal Death in Patients with Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–A pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest cardiovascular outcomes trial of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, showed that FARXIGA (dapagliflozin) reduced the progression of kidney disease or renal death in patients with type 2 diabetes (T2D). These data, presented …

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FDA Grants Priority Review to Invokana sNDA for Treatment of Chronic Kidney Disease Patients with Type 2 Diabetes

RARITAN, N.J., May 22, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling …

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Victoza Demonstrated Superiority in Reducing Blood Sugar vs Placebo in Children and Adolescents with Type 2 Diabetes

BALTIMORE, April 28, 2019 /PRNewswire/ — Novo Nordisk today announced the results from the ELLIPSE trial which examined efficacy and safety and demonstrated superiority of Victoza® (liraglutide) injection 1.8 mg vs placebo in reducing blood sugar in children and adolescents aged 10-17 with type 2 diabetes.1 ELLIPSE is the first …

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Pfizer Exercises Option to License AnTolRx’s Immune Tolerance Therapy for Treatment of Type 1 Diabetes

CAMBRIDGE, Mass., March 5, 2019 /PRNewswire/ — AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance, today announced that Pfizer Inc. (NYSE: PFE) has exercised the option granted under a June 2016 agreement to license an immune tolerance therapy from AnTolRx’s Type 1 diabetes research program. The …

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Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management

DUBLIN – February 19, 2019 – Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL technology is designed to automate insulin …

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FDA Committee Votes in Favor of Approving Zynquista, an Investigational Dual SGLT1 and SGLT2 Inhibitor, as Treatment for Type 1 Diabetes

PARIS and THE WOODLANDS, TX – January 17, 2019 – The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of Zynquista(TM)* (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral …

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