Zydus, a global pharmaceutical company, has secured permission from CDSCO, India, to kickstart the Phase I clinical study of its groundbreaking PCSK9 inhibitor. This Phase I study, characterized by its prospective, randomized, double-blind, and placebo-controlled design, is poised to explore the safety and tolerability of the subcutaneously administered anti-PCSK9 product in healthy human volunteers. Cardiovascular […]
Pharmaceutical giant Merck has announced the initiation of its groundbreaking Phase 3 clinical program, CORALreef, focusing on MK-0616—a novel, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. MK-0616 is being evaluated for the treatment of adults suffering from hypercholesterolemia. The CORALreef program marks a historic milestone as the first Phase 3 clinical program for an […]
Regeneron Pharmaceuticals and Sanofi have received a significant boost with the European Commission’s (EC) approval of Praluent (alirocumab) for a new indication. The approval enables Praluent to be used as an adjunct treatment to reduce low-density lipoprotein cholesterol (LDL-C) levels in adults with atherosclerotic cardiovascular disease (ASCVD), aiming to lower the risk of further cardiovascular […]
Check out Repatha FDA approval news where we will tell you about the approval of the Amgen cholesterol drug for the prevention of heart attack and stroke.
In a significant advancement for cardiovascular disease management, Amgen’s Repatha (evolocumab) has received approval from the U.S. Food and Drug Administration (FDA) to prevent heart attacks, strokes, and coronary revascularizations in adults with heart disease. This marks the first approval of a PCSK9 inhibitor for these specific conditions, highlighting a major step forward in the […]