Medicare plans can now cover Wegovy for patients at risk of heart disease

For the first time, Medicare will allow coverage of one of the new blockbuster weight-loss drugs for enrollees in Part D plans. The plans may now cover Wegovy when prescribed to prevent heart attacks and strokes, according to a new policy issued this week from the Centers for Medicare and Medicaid Services. Read more…

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U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C…

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PRALUENT® (ALIROCUMAB) INJECTION RECEIVES FDA APPROVAL TO TREAT CHILDREN WITH GENETIC FORM OF HIGH CHOLESTEROL

TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). Read more…

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Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity

PLAINSBORO, N.J., March 8, 2024 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Wegovy® to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight along with a reduced calorie…

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Medtronic announces FDA approval of minimally invasive device to treat hypertension

DUBLIN, Nov. 17, 2023 /PRNewswire(opens new window)/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization. Read…

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INPEFA® (sotagliflozin) Use Associated With Early Clinical Benefit in Heart Failure and Atherosclerotic Events in Analysis of Clinical Data

The Woodlands, Texas, November 12, 2023 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post hocanalysis of clinical data from the SCORED trial demonstrated that clinical benefit from INPEFA® (sotagliflozin) use in heart failure (HF) and major adverse cardiovascular events (MACE) related outcomes was observed as early as approximately three months in patients at high risk for cardiovascular…

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Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial

Bagsværd, Denmark, 8 August 2023 – Novo Nordisk today announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years. The trial enrolled 17,604 adults…

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FDA Approves Lilly’s Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Option for the Treatment of Obesity or Overweight with Weight-Related Medical Problems

INDIANAPOLIS, Nov. 8, 2023 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater), or those…

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Interim Data from the heart-1 Phase 1b Clinical Trial of VERVE-101 in Patients with HeFH to be Presented at the American Heart Association (AHA) Scientific Sessions

Interim Data from the heart-1 Phase 1b Clinical Trial of VERVE-101 in Patients with HeFH to be Presented at the American Heart Association (AHA) Scientific Sessions 2023 on November 12 at 3:30 p.m. ET; Company to Host Investor Event and Webcast on November 12 at 6:30 p.m. ET BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) —…

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Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Palo Alto, Calif. – November 7, 2023 – Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension. Read more…

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