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…
Read MoreINPEFA® (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…
Read MoreNovo 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…
Read MoreFDA 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…
Read MoreInterim 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) —…
Read MoreRecor 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…
Read MoreASPC partners with Endless Health to support testing attendees’ cholesterol levels at family practice conference
Dallas, TX. — The American Society for Preventive Cardiology (ASPC) together with Endless Health will be at the American Academy of Family Physicians’ (AAFP) annual conference – Family Medicine Experience (FMX) – in Chicago, IL October 27-29, 2023 – offering attendees the ability to test their lipid and metabolic levels with a simple finger stick…
Read MoreNovartis will appeal to U.S. Court of Appeals to uphold validity of Entresto® combination patent; maintains 2023 guidance and mid-term outlook
Basel, July 07, 2023 — Novartis today announced that the U.S. District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity. Novartis strongly believes the combination patent is valid and will appeal to…
Read MoreUS FDA approves expanded indication for Novartis Leqvio® (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease
EAST HANOVER, N.J., July 10, 2023 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1. This patient population includes those…
Read MoreLEXICON ANNOUNCES FDA APPROVAL OF INPEFA™ (SOTAGLIFLOZIN) FOR TREATMENT OF HEART FAILURE
The Woodlands, Texas, May 26, 2023 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: Read more…
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