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Endocrinology

FDA Approves Invokana to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in T2D and DKD

RARITAN, N.J., Sept. 30, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in …

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FDA Approves Rybelsus, the First GLP-1 Analog Treatment Available in a Pill for Adults with Type 2 Diabetes

PLAINSBORO, N.J., Sept. 20, 2019 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus® (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).1 Rybelsus® is the first and only glucagon-like peptide-1 (GLP-1) analog …

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Medtronic and Novo Nordisk Enter Agreement to Provide Integrated Digital Solutions for People with Diabetes

DUBLIN and BAGSVÆRD, Denmark, Sept. 16, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), and Novo Nordisk A/S today announced a collaboration that will develop solutions to integrate insulin dosing data from future Novo Nordisk smart insulin pens into Continuous Glucose Monitoring (CGM) devices from Medtronic, such as the Guardian™ Connect system. People with …

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FDA Approves Xeris Pharmaceuticals’ Gvoke Injection for the Treatment of Severe Hypoglycemia

CHICAGO–(BUSINESS WIRE)–Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for GVOKE™ (glucagon) injection, its ready-to-use, room-temperature stable liquid …

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Vertex to Pay $950 Million to Acquire Stem Cell Biotech Semma Therapeutics

BOSTON & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the company has entered into a definitive agreement under which Vertex will acquire Semma Therapeutics, a privately held biotechnology company pioneering the use of stem cell-derived human islets as a potentially curative treatment for type 1 diabetes, for …

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Positive Results Highlight Potential of Bempedoic Acid / Ezetimibe Combination for Hypercholesterolemia with Type 2 Diabetes

MUNICH–(BUSINESS WIRE)–Daiichi Sankyo Europe GMbH (hereafter, ‘Daiichi Sankyo’) today announced positive initial results from the 12-week Phase 2 bempedoic acid / ezetimibe fixed dose combination (FDC) tablet study (also known as Study 058). Bempedoic acid and its FDC tablet with ezetimibe are currently undergoing regulatory review for marketing authorisation by …

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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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