7 Cardiology Headlines You Missed in December 2025

In the cardiology world, 2025 went out with a bang – December saw a series of key approvals from the US Food and Drug Administration (FDA) and data from key trials, including CeleBrate and SUMMIT-MAC. With aficamten tablets and lerodalcibep-liga, among other medications, receiving their approvals, the FDA opened new treatment pathways for several debilitating diseases last month.

As we enter 2026, the HCPLive editorial team has collected 7 of the most impactful headlines from December 2025 – catch up on any news you might have missed over the holidays below.

FDA News

FDA Approves FUROSCIX On-Body Injector for Pediatric Patients, Accepts sNDA for ReadyFlow Autoinjector

On December 23, 2025, the FDA announced its approval of the FUROSCIX On-Body Infusor for the treatment of edema associated with chronic heart failure (HF) and chronic kidney disease (CKD) in pediatric patients. Previously approved in 2022 and 2025 for chronic HF and CKD in adults, respectively, this third approval fulfills all post-marketing requirements outlined in the initial approval letter. Additionally, the FDA accepted a supplemental NDA for the FUROSCIX ReadyFlow Autoinjector, which is designed to administer a subcutaneous furosemide injection in <10 seconds. If approved, this device could eliminate the need for hospital admission for patients with fluid buildup.

FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

On December 19, 2025, parent company Cytokinetics announced the FDA’s approval of aficamten 5 mg, 10 mg, 15 mg, and 20 mg tablets under the brand name Myqorzo for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aiming to improve functional capacity and symptoms. The decision is based on positive data from the phase 3 SEQUOIA-HCM clinical trial, during which patients receiving aficamten for 24 weeks saw substantially improved exercise capacity compared to placebo, with increased oxygen uptake across all prespecified subgroups.

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

On December 15, 2025, the FDA approved lerodalcibep-liga, under the brand name Lerochol, to reduce LDL-C in patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The small protein-binding third-generation PCSK9 inhibitor is administered as a once-monthly, single small-volume subcutaneous injection. Positive data from the LIBerate program, a series of 5 phase 3 registration studies including 2900 patients, contributed to the FDA’s approval; most recently, the LIBerate-HoFH trial proved lerodalcibep’s noninferiority to evolocumab with no treatment-related serious adverse events.

FDA Approves Etripamil (Cardamyst) Nasal Spray for PSVT

Announced on December 12, 2025, by parent company Milestone Pharmaceuticals, the FDA’s approval of etripamil nasal spray marks the first rapid-acting treatment option for patients with paroxysmal supraventricular tachycardia (PSVT) to receive approval for use outside of the emergency department. This novel calcium channel blocker nasal spray was developed to treat frequent and highly symptomatic PSVT episodes and is designed to be self-administered by patients. With this approval, patients are now afforded more control over their condition.

Trial Results

Mavacamten Monotherapy Improves Cardiac Function in oHCM, With Ozlem Bilen, MD

The COLLIGO-HCM trial has shown mavacamten’s efficacy in improving cardiac function and symptoms in patients with obstructive hypertrophic cardiomyopathy (HCM) via substantial NYHA functional class, Valsalva LVOT gradient, and LVEF improvements. Ozlem Bilen, MD, associate professor of medicine in the cardiology division and chief of cardiology at Emory University Hospital, discusses the promise of mavacamten’s proven efficacy and safety, ultimately predicting a guideline update for HCM based on these data.

CeleBrate: Zalunfiban Administration at First Contact Improves STEMI Outcomes, With C. Michael Gibson, MD

Zalunfiban, a subcutaneous glycoprotein IIb/IIIa inhibitor, met its primary efficacy and safety endpoitns in the CeleBrate phase 3 trial, investigating the drug for administration at first contact to patients with suspected ST-segment elevation myocardial infarction. The editorial team met with C. Michael Gibson, MD, an interventional cardiologist and the chief executive officer of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School, to discuss the implications of these data for the historically poor mortality rates among patients with STEMI.

SUMMIT-MAC: Tendyne System Improves Survival in MAC, With Paul Sorajja, MD

Patients with severe mitral annular calcification (MAC) exhibited substantially reduced all-cause mortality after transcatheter mitral valve replacement with Abbott’s Tendyne implant, based on the SUMMIT-MAC interventional trial. We spoke with Paul Sorajja, MD, associate director of the Banner – University Medical Heart Institute and professor of medicine at the University of Arizona, to discuss how this system could revolutionize a traditionally difficult-to-treat condition.