News

FDA approves Yutrepia, inhaled treprostinil, for PAH and PH-ILD

The U.S. Food and Drug Administration (FDA) has approved Yutrepia, Liquidia’s inhaled dry powder formulation of treprostinil, for improving exercise capacity in people with pulmonary hypertension (PH) associated with interstitial lung disease, known as PH-ILD, and pulmonary arterial hypertension, or PAH. Yutrepia had previously held tentative approvals…

Ultrasound device for PH nets FDA breakthrough device designation

The U.S. Food and Drug Administration (FDA) has granted breakthrough device status to the Gradient Denervation System, an ultrasound-based catheter for treating pulmonary hypertension (PH). A breakthrough designation is given to medical devices that may offer significant advantages over existing treatments for irreversibly debilitating or life-threatening conditions. It’s intended…

Pulmonary hypertension common in heart dysfunction patients

Nearly two-thirds of patients with left ventricular diastolic dysfunction (LVDD) — in which the heart struggles to relax and fill with blood between heartbeats — also have pulmonary hypertension, a study found, and the condition is more likely if a person has an enlarged left atrium (the heart’s upper…

PAH treatment Opsynvi endorsed by patients, clinicians

Treatment with Opsynvi (macitentan and tadalafil) as a single-tablet combination therapy for people with pulmonary arterial hypertension (PAH) is highly valued by patients and endorsed by clinicians, according to interviews conducted during the Phase 3 A DUE trial. All patients interviewed said that a single, once-a-day pill to…

Algorithm can accurately diagnose pulmonary hypertension: Study

Corvista Health’s machine-learned algorithm can accurately diagnose pulmonary hypertension (PH) in a noninvasive way by assessing the elevation of mean pulmonary arterial pressure (mPAP), a study showed. The point-of-care system is based on a procedure that can be conducted during medical appointments in under five minutes, with patients…

Combination treatment extends survival in PH, pulmonary fibrosis

Combining pulmonary vasodilators, medications that widen blood vessels, and antifibrotics, which slow the progression of scarring, may prolong survival and time without needing a transplant in people with both pulmonary hypertension (PH) and pulmonary fibrosis, a study suggested. “Antifibrotic and pulmonary vasodilator therapy could improve transplant-free survival in…

Suppressing NEK2 may reverse vascular remodeling in PAH: Study

Reducing the levels of the protein NEK2 in the pulmonary arteries lessened disease-driving changes in blood vessels and the heart of a rat model of pulmonary arterial hypertension (PAH) due to congenital heart disease (CHD). The effects were tied to a modulation of the NF-kB pathway involved in vascular…

Synhale acquires telaglenastat for PH, now planning Phase 2 trial

Synhale Therapeutics has acquired the rights to the experimental therapy telaglenastat (CB-839), which has previously been tested as a potential cancer therapy. The company is planning to launch a Phase 2 clinical trial to test telaglenastat in people with pulmonary hypertension (PH). “This acquisition represents a unique opportunity to…

Pivotal study for noninvasive PH test is now underway

The first patient has been enrolled in a pivotal study testing the accuracy of Sensydia’s noninvasive Cardiac Performance System (CPS) for measuring cardiovascular function, including pulmonary artery pressure, a key metric used to diagnose and monitor pulmonary hypertension (PH). The multi-center, observational trial (NCT06870591) will compare CPS…

Cereno aligns with FDA on CS1 development path for PAH

Cereno Scientific has completed a type C meeting with the U.S. Food and Drug Administration (FDA) about the design of a future Phase 2b clinical trial to test CS1, its lead therapy candidate for people with pulmonary arterial hypertension (PAH). Besides defining the trial’s design, the meeting, held…