9 Cardiology Headlines You Missed in July 2025

Cardiology saw a flurry of activity from the US Food and Drug Administration (FDA) in July 2025, with new approvals, label expansions, and regulatory updates reflecting a dynamic treatment and increasing emphasis on personalized care across several forms of cardiovascular disease, including heart failure, lipid disorders, arrhythmias, and cardiometabolic disease.

Together, these developments offer a clear view of where cardiology is headed—toward broader access, greater personalization, and targeted efficacy across risk profiles. Below is a roundup of the key regulatory and pipeline developments in cardiovascular health from June.

FDA Approvals in Cardiology from July 2025

FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease

On July 14, 2025, the FDA approved an update to the irrigation flow rate of the VARIPULSE Platform, a pulsed field ablation (PFA) system for drug-refractory paroxysmal atrial fibrillation. According to Johnson & Johnson MedTech, the update aims to enhance irrigation and support more consistent, safe outcomes, building on more than 10,000 procedures performed globally with a <0.5% neurovascular adverse event rate. The platform integrates the VARIPULSE catheter with the CARTO 3 system, offering real-time catheter visualization, lesion tagging, and tissue proximity feedback to optimize ablation efficacy.

FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More

On July 14, 2025, Bayer announced FDA approval of finerenone (Kerendia) for reducing the risk of cardiovascular death, heart failure hospitalization, and urgent heart failure visits in adults with heart failure with LVEF ≥40%. Based on data from the phase 3 FINEARTS-HF trial, the drug showed a 16% relative risk reduction in the primary composite outcome compared to placebo. According to Bayer, this marks the first FDA-approved nonsteroidal MRA for HFpEF and HFmrEF, positioning it as a second pillar of therapy alongside SGLT2 inhibitors.

Related Content: Finerenone's FDA Approval Marks a Turning Point in HFpEF Management

FDA Approves Inclisiran (Leqvio) Label Update as First-Line Monotherapy in Hypercholesterolemia

On July 31, 2025, Novartis announced FDA approval of a label update for inclisiran (Leqvio), allowing its use as monotherapy with diet and exercise to lower LDL-C in adults with hypercholesterolemia. Based on robust LDL-C reduction data, the update removes the prior requirement for use alongside statins and refines the indication terminology. According to Novartis, this change enables broader, earlier use of inclisiran in lipid management.

FDA Submissions & Regulatory Updates

FDA Accepts Application for Sotatercept-csrk Label Expansion in PAH

On July 2, 2025, the FDA granted Priority Review to Merck’s supplemental Biologics License Application (sBLA) for sotatercept-csrk (WINREVAIR), aiming to update its label for pulmonary arterial hypertension (PAH, Group 1 PH). The submission is based on results from the Phase 3 ZENITH trial, which showed a 76% reduction in major morbidity and mortality events in high-risk PAH patients on background therapy. Originally approved in 2024, sotatercept is a first-in-class activin signaling inhibitor. The FDA’s PDUFA action date is set for October 25, 2025.

FDA Accepts Response to CRL for Etripamil (Cardamyst) for Treating PSVT

On July 11, 2025, the FDA accepted Milestone Pharmaceuticals’ response to the Complete Response Letter (CRL) for etripamil (Cardamyst) nasal spray, a self-administered therapy for paroxysmal supraventricular tachycardia (PSVT). A new PDUFA target action date of December 13, 2025, has been set.

The original NDA was supported by data from the RAPID trial, which showed etripamil’s superiority over placebo for converting PSVT episodes within 30 minutes. The CRL had cited chemistry and manufacturing concerns, specifically regarding nitrosamine impurities and facility inspection. Milestone addressed these issues by conducting in-vitro studies and transitioning testing to FDA-inspected vendors.

FDA Issues CRL to Deramiocel for Treating Cardiomyopathy Secondary to DMD

On July 11, 2025, Capricor Therapeutics received a CRL from the FDA for its BLA for deramiocel, a proposed treatment for Duchenne muscular dystrophy (DMD)-associated cardiomyopathy. The CRL cited insufficient evidence of effectiveness and unresolved CMC issues.

Capricor plans to resubmit the BLA in Q3 2025, incorporating additional data from the ongoing HOPE-3 trial, which is expected to report topline results later this year. Deramiocel, made from allogeneic cardiosphere-derived cells, was previously granted Priority Review based on Phase 2 HOPE-2 trial data showing cardiac benefits.

Pipeline News and Other Updates

SURPASS-CVOT: Tirzepatide Bests Dulaglutide for Cardiovascular Protection

On July 31, 2025, Eli Lilly and Company announced topline results from the phase 3 SURPASS‑CVOT trial comparing tirzepatide (Mounjaro) to dulaglutide (Trulicity) in adults with type 2 diabetes and established ASCVD. Based on outcome data, tirzepatide met the primary non‑inferiority endpoint for 3-point major adverse cardiovascular events (HR, 0.92), while also showing additional benefits in A1C, weight reduction, renal preservation, and a 16% reduction in all‑cause mortality (HR, 0.84). According to Eli Lilly, a submission, backed by this data, is expected before the close of 2025.

Related Content: Diabetes Dialogue: Tirzepatide and SURPASS-CVOT Topline Results

Baxdrostat Meets Efficacy Endpoint in Phase 3 Trial for Resistant Hypertension

On July 14, 2025, AstraZeneca announced that baxdrostat, a potential first-in-class aldosterone synthase inhibitor, met the primary endpoint of significant systolic blood pressure reduction in the phase 3 BaxHTN trial. Based on 12-week data from a randomized, placebo-controlled study of patients with difficult-to-control hypertension, baxdrostat 2 mg once daily demonstrated greater reductions in seated systolic blood pressure compared with placebo. The treatment was generally well tolerated and showed no impact on cortisol levels. Results will be presented in a late-breaking session at the European Society of Cardiology Congress and shared with regulatory agencies globally.