Tag: FDA label expansion

FDA Approvals (July 2024 – January 2025): Advancements in Cardiorenal and Cardiometabolic Health 

Get the latest FDA-approved drugs and devices for cardiometabolic and cardiorenal conditions and risk factors. Explore now!

2024’s Mid-Year Review: FDA-Approved Cardiorenal Metabolic Drugs and Devices 

The first half of 2024 ushered in a wave of transformative FDA approvals in cardiorenal metabolic health. Get up to date now!

FDA Extends Approval for Alirocumab to Lower LDL-C in Pediatric Patients with HeFH 

Addressing an Unmet Need in Pediatric Patients with HeFH  Heterozygous familial hypercholesterolemia (HeFH) affects about 1 in 313 people—characterized by dangerously high low-density lipoprotein cholesterol (LDL-C) levels. Untreated, it can trigger early heart disease. Detecting and treating it early in pediatric patients can prevent heart problems later. American College of Cardiology/American Heart Association guidelines define acceptable LDL-C […]

FDA Expands Labels for Bempedoic Acid Tablets and Combination Bempedoic Acid and Ezetimibe Tablets to Reduce Cardiovascular Risk 

Introduction: Addressing the Need for Improved LDL Management in the US  There is a clear need for innovative treatments to combat cardiovascular disease (CVD).  Heart disease remains the leading cause of death for men and women. 80% of heart attacks and strokes linked to CVD are preventable with optimal risk factor management. However, every 40 seconds, an individual […]