Endocrinology

FDA Approves Lyumjev, Lilly’s New Rapid-Acting Insulin

INDIANAPOLIS, June 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s (NYSE: LLY) new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev is a novel formulation of insulin lispro, developed to speed …

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FDA Approves Trulicity for Reduction of Major CV Events in Adults with Type 2 Diabetes with CV Disease or Multiple Cardiovascular Risk Factors

INDIANAPOLIS, Feb. 21, 2020/PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Trulicity® (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors. This decision makes Eli Lilly and Company’s (NYSE: LLY) Trulicity the first and only type …

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New Research Shows EarlySign’s AI Solution Can Identify Prediabetic Patients at High Risk of Developing Diabetes

TEL AVIV, Israel, Jan. 22, 2020 /PRNewswire/ — Medial EarlySign (earlysign.com), a leader in machine learning-based solutions to aid in the early detection and prevention of high-burden diseases, today announced the results of a new study assessing the effectiveness of its Pre2D-Flag AlgoMarker™ algorithmic model to identify individuals at high …

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FDA Approves Ozempic to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes and Known Heart Disease

PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 …

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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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