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AP02, an inhaled form of nintedanib being developed by Avalyn Pharma for idiopathic pulmonary fibrosis (IPF), was generally well tolerated and resulted in higher lung levels of the drug than oral nintedanib, according to findings from two Phase 1 trials. An oral formulation of nintedanib, sold as Ofev,…

An experimental oral treatment called taladegib helped expand lung volume and reduce scarring in people with idiopathic pulmonary fibrosis (IPF), according to a new imaging analysis from a clinical trial. Data from the Phase 2a trial (NCT04968574), generated using artificial intelligence (AI) to evaluate high-resolution chest scans, were…

The U.S. Food and Drug Administration (FDA) will decide by early next year whether or not to expand its approval of nebulized Tyvaso (treprostinil) — an inhaled treatment for people with certain lung diseases — to allow its use in idiopathic pulmonary fibrosis (IPF), a respiratory condition marked…

September is Pulmonary Fibrosis Awareness Month, and advocates around the globe are joining together to shine a light on what it means to live with pulmonary fibrosis (PF), a condition characterized by lung scarring and marked by breathing problems. “It is a lonely feeling to have a chronic disease…

The U.S. Food and Drug Administration (FDA) has given fast track designation to LTI-03, an inhaled therapy candidate that Rein Therapeutics is developing for idiopathic pulmonary fibrosis (IPF). Fast track status is intended to facilitate the development and review of drugs that treat serious conditions and address unmet…

According to its U.S. developer, the first of two global clinical trials designed to test Haduvio (nalbuphine extended-release) — a potential treatment for chronic cough due to idiopathic pulmonary fibrosis (IPF) — is now underway, with the second expected to launch later this year. The initial Phase 3 trial,…

The inhaled therapy MNKD-201 was tolerated well in people with idiopathic pulmonary fibrosis (IPF) in a Phase 1 clinical trial, and a Phase 2 study to further test it is underway, the treatment’s developer said. The Phase 2 trial, INFLO-2 (NCT07679893), aims to enroll more than 200 adults…

An international clinical trial testing LTI-03, Rein Therapeutics’ inhaled treatment candidate for idiopathic pulmonary fibrosis (IPF), is now recruiting participants at sites in five countries. The Phase 2 trial, dubbed RENEW (NCT06968845), aims to enroll approximately 120 people with IPF, ages 40 and older. Eligible participants will…

The oral therapy Jascayd (nerandomilast) has been approved in the European Union for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The marketing authorization from the European Commission follows a positive recommendation from a regulatory committee and marks the first new IPF therapy approved…