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FDA Rejects Lexicon’s NDA for Sotagliflozin for Treatment of Patients with Type 1 Diabetes

The Woodlands, Texas, December 2, 2019 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the Office of New Drugs of the U.S. Food and Drug Administration (FDA) has reiterated the FDA’s prior position and denied Lexicon’s appeal of the Complete Response Letter in relation to the New Drug Application for …

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FDA Advisory Committee Votes Against Approval of Empagliflozin as an Adjunct to Insulin for Patients with Type 1 Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 13, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14 to 2 that the benefits of empagliflozin 2.5 mg do not outweigh the risks to support approval as an adjunct to insulin for adults with …

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FDA Approves Fiasp for Use in Insulin Infusion Pumps for Adults with Type 1 or Type 2 Diabetes

PLAINSBORO, N.J., Oct. 22, 2019 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp®, a …

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FDA Approves AstraZeneca’s Farxiga to Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved FARXIGA (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. The approval is based on …

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Abbott and Omada Health Partner to Offer Integrated Digital Health and Coaching Experience for People with Type 2 Diabetes

ABBOTT PARK, Ill. and SAN FRANCISCO, Oct. 14, 2019 /PRNewswire/ — Abbott (NYSE: ABT) and Omada Health announced today they are partnering to integrate Abbott’s revolutionary FreeStyle Libre system, a continuous glucose monitoring (CGM) technology, with Omada Health’s pioneering digital care program, aiming to create a new paradigm for people …

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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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