Author: Ken Dropiewski

Shape Memory Medical Announces First Patient Treated in the EMBO-Post Market Surveillance Registry in Germany

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the first patient treated in Germany as part of the EMBO-Post Market Surveillance Registry, the Company’s prospective, multicenter, registry study of its IMPEDE and IMPEDE-FX Embolization Plugs when used for peripheral vascular […]

United Therapeutics Corporation Reports Fourth Quarter and Full Year 2022 Financial Results

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the fourth quarter and year ended December 31, 2022. Full year total revenues rose to a record $1.94 billion, as U.S. patients being treated with the company’s […]

AMGEN ANNOUNCES CARDIOVASCULAR STUDY TO EVALUATE ASSOCIATION BETWEEN LIPOPROTEIN(a) AND CARDIOVASCULAR RISK IN AFRICAN AMERICANS

Unique Community-Based Partnership With the Association of Black Cardiologists and Morehouse School of Medicine to Identify Study Sites and Participants Observational Study to Better Understand Associations Between Lp(a) Levels and Atherosclerotic Cardiovascular Disease (ASCVD) in an Underrepresented Patient Population THOUSAND OAKS, Calif., Feb. 22, 2023 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the African American […]

Medtronic reports third quarter fiscal 2023 financial results

Delivers top and bottom line ahead of expectations, with strength in Cardiovascular and Neuroscience portfolios DUBLIN, Feb. 21, 2023 /PRNewswire/ — Medtronic plc (NYSE:MDT) today announced financial results for its third quarter of fiscal year 2023, which ended January 27, 2023. Key Highlights Revenue of $7.7 billion was flat as reported and increased 4.1% organic, […]

Mezzion Pharma Submits Protocol for Confirmatory Pivotal Phase 3 Trial (“FUEL-2”) in Fontan Subjects

SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA). In the Type B meeting between the FDA and Mezzion, the FDA provided Mezzion with a clear path forward […]

CinCor Pharma Announces Receipt of Minutes from End-of-Phase 2 Meeting with the U.S. Food and Drug Administration on Planned Phase 3 Program of Baxdrostat

WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor” or the “Company”) announced today completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) on the anticipated Phase 3 program for baxdrostat in hypertension. Baxdrostat is a once daily potentially first-in-class, highly selective […]

Alnylam Announces U.S. Food and Drug Administration (FDA) Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

– PDUFA Date Set for October 8, 2023 – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the […]

Medtronic Receives CE Mark for Extravascular Defibrillator System That Treats Abnormal Heart Rhythms

EV-ICD defibrillation lead placed outside of heart and veins, preserving vasculature DUBLIN, Feb. 17, 2023 /PRNewswire/ — Medtronic plc (NYSE:MDT) has received CE (Conformité Européenne) Mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden […]