Tag: FDA

AltaThera Pharmaceuticals Announces FDA Approval for New Indications of Sotalol IV: A New and Faster Way to Initiate Sotalol Therapy for Atrial Fibrillation (AFib) Patients

– Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients – New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day – The […]

FDA Inks Research Collaboration Agreement with AnaBios Focused on Human Primary Cardiomyocytes

SAN DIEGO, March 10, 2020 /PRNewswire/ — Today, AnaBios announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function. Under the […]

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

– NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins – – First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved – – Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the […]

Cardiovalve Receives ‘Breakthrough Device Designation’ for Its Transcatheter Tricuspid Valve Replacement System

Cardiovalve becomes first privately held company to receive FDA’s early feasibility study (EFS) approval for both tricuspid regurgitation (TR) and mitral regurgitation (MR) indications OR YEHUDA, Israel–(BUSINESS WIRE)–Cardiovalve announced today that it has received U.S. Food and Drug Administration (FDA) approval for […]

RIST Neurovascular, Inc. Announces FDA Clearance of the First Catheter Specifically Designed to Access the Neurovasculature through the Radial Artery

RIST Cath device enables a radial approach during neurointerventional procedures for introduction of devices into the neurovasculature MIAMI BEACH, Fla.–(BUSINESS WIRE)–RIST Neurovascular, Inc., a neuro-interventional medtech company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance […]