Cardiology

Announced on March 28, 2025, the FDA's CRL to Milestone Pharmaceuticals cites CMC issues, but no issues with safety or efficacy data.

OAC-naive patients experienced a significantly smaller increase in stroke or systemic embolism with asundexian than apixaban.

A look at 7 phase 2 and phase 3 trials with significant implications from ACC 2025's late-breaking and featured clinical research sessions.

First Procedure Performed at AHN Wexford Hospital, Demonstrating Network’s Ongoing Commitment to Bringing Complex Cardiovascular Care into the Community

A Q2 2025 preview spotlighting 10 FDA decisions to watch, including upcoming PDUFAs for dupilumab, pz-cel, ketamine, clesrovimab, and more!

The IND submission for VERVE-102 was supported by interim data from the dose-escalation portion of the ongoing Heart-2 Phase 1b clinical trial.

Our top 5 headlines featured new migraine guidelines, the benefit of automated insulin delivery for type 2 diabetes, and 3 key FDA decisions.

Bhatt previews 3 late-breaking clinical trials being presented at this year's American College of Cardiology Annual Scientific Sessions.

The approval expands the indication for vutrisiran, which becomes the first therapeutic approved by the FDA for the treatment of ATTR-CM.

AID technology outperformed CGM alone to reduce HbA1c, without increasing hypoglycemia, in adults with insulin-treated type 2 diabetes.

Initiation of the MOMENTUM clinical trial will explore the prevalence of endogenous hypercortisolism in patients with resistant hypertension.

If approved, this indication targets the treatment of adult patients with heart failure with a left ventricular ejection fraction of ≥40%.

In this episode, hosts discuss the impact of recently launched direct, cash pay options for people using semaglutide and tirzepatide.

Our top 5 headlines featured an oral drug delivering 16% weight loss, notable blood pressure reductions from a hypertension treatment, and 3 key FDA decisions.

Food insecurity remained associated with incident CVD after adjustment for socioeconomic factors among participants in the 2000-2020 CARDIA study period.

The novel controlled metabolic accelerator significantly reduced fat-specific body weight but showed no improvements in exercise capacity over 19 weeks.

A study of 3 large US cohorts found a higher intake of butter was linked to greater mortality rates, while plant-based oil intake lowered total mortality.

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.