Cardiology

The regulatory agency granted 510(k) clearance to Caristo Diagnostics' image analysis software to aid in coronary artery disease diagnosis.

Fonarow describes a revised classification of glucose levels that breaks down the normal range into lower and higher levels of associated cardiovascular risk.

Topline data from the pivotal Launch-HTN and Advance-HTN trials met primary endpoints, supporting lorundrostat for uncontrolled or resistant hypertension.

The regulatory agency accepted the BLA's filing and assigned a target action date of August 31, 2025.

The agency approved the first generic of the anticoagulant rivaroxaban to lower the risk of cardiovascular and thromboembolic events in adults with CAD and PAD.

Marking the first stroke medicine approved in nearly 30 years, the single five-second intravenous bolus provides faster administration than the standard of care.

The February 2025 cardiology review covers pipeline updates in lipid management, key regulatory acceptances and approvals, and shifting ASCVD trial endpoints.

This FDA News Month in Review provides a round-up of regulatory decisions from February 2025.

New data from the REDUCE-IT trial suggests icosapent ethyl offers benefit even among those with LDL-C less than 55 mg/dL.

Finerenone reduces outpatient worsening HF in patients with mildly reduced or preserved ejection fraction in a secondary analysis of FINEARTS-HF.

In this Diabetes Dialogue segment, hosts discussed the strengths of trial diversity and HbA1c reductions with automated insulin delivery in type 2 diabetes.

With this FDA approval, chenodiol tablets become the first approved drug to treat CTX, a rare lipid storage disease.

The US supply of semaglutide and semaglutide 2.4 mg now meets or exceeds current and projected demand, ending the long-running shortages of these blockbuster drugs.

Iron deficiency was more common in acute versus chronic heart failure, with notable differences in detection by numerous recommended definitions.

Dual SGLT1/2 inhibition with sotagliflozin significantly reduced both heart attacks and stroke in a prespecified secondary analysis of the SCORED trial.

Large ASCVD randomized controlled trials in prominent journals often use heterogeneous endpoints, which could influence reported results.

Our top 5 headlines include a target date for a cholesterol-lowering drug, long-term dermatology data, and an expanded dosing label for geographic atrophy.

Cardiovascular clinical outcome trials require a large number of sites to meet enrollment targets, but patient-per-site ratios were often low.

Mehrdad Ghoreishi, MD explores the latest advances in aortic disease treatment and the role of minimally invasive techniques.

Olpasiran sustained reductions in oxidized phospholipids on apoB in patients with ASCVD and elevated Lp(a) levels in the Phase 2 dose-ranging trial.

Cardiovascular hospitalization rates were higher in the US than in Denmark, driven by a significant increase in heart failure and myocardial infarction hospitalizations.

Announced by LIB Therapeutics Inc., the agency has set a PDUFA target action date of December 12, 2025.

Use of medications for secondary CVD prevention is low globally, and in most country income-level groups, with no indication of improvement.

SGLT2 inhibitors lower the risk of MACE in older age, despite smaller HbA1c reductions, while GLP-1 RAs were more cardioprotective in younger individuals with T2D.

A new tool may enable earlier identification of heart failure, potentially reducing hospitalizations and premature death.