News

Beyond Air seeks FDA OK for new LungFit PH 2 NO device

Beyond Air has submitted a supplement application to the U.S. Food and Drug Administration (FDA) for its LungFit PH 2, a second-generation device for administering nitric oxide (NO) to treat persistent pulmonary hypertension of the newborn (PPHN). LungFit PH 2 is a smaller, lightweight, transport-ready version of the…

TPIP may improve circulation, exercise capacity in PAH: Study

A Phase 2b clinical trial of Insmed’s treprostinil palmitil inhalation powder (TPIP) suggested daily doses of the inhaled dry powder are well tolerated and may improve blood flow and exercise capacity in adults with pulmonary arterial hypertension (PAH). “The statistically significant and clinically meaningful results shown with TPIP…

HB-1614 may increase exercise capacity in PH-ILD: Clinical trial

A Phase 2a study of HB-1614, an oral therapy candidate, suggested the medication is safe and may improve exercise capacity and quality of life in adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD). This is according to Halo Biosciences, developer of HB-1614, which announced the publication of…

Liquidia working to bring Yutrepia to US market after FDA approval

Soon after Yutrepia (treprostinil) was approved by the U.S. Food and Drug Administration (FDA) to treat some forms of pulmonary hypertension, the therapy’s maker, Liquidia, scheduled its first commercial shipment to specialty pharmacies. “We have moved with exceptional speed to provide a new and differentiated therapeutic alternative to the…

Low-dose metformin reformulation shows promise in PAH rats

Low-dose metformin, a medication for type 2 diabetes, delivered to the pulmonary arteries using lipid-based nanocapsules, safely eased signs of pulmonary arterial hypertension (PAH) in rats, a study reports. “Administration of [metformin] nanocapsules is a safe and innovative therapeutic approach for PAH,” the researchers wrote. “This method could improve…

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…