United Therapeutics Says FDA Accepts Supplemental Filing for Nebulized Tyvaso in IPF

07:25 AM EDT, 09/02/2026 (MT Newswires) -- United Therapeutics (UTHR) said Wednesday the US Food and Drug Administration has accepted its supplemental new drug application for nebulized Tyvaso inhalation solution to treat idiopathic pulmonary fibrosis, or IPF. The application was based on the combined analyses of the results of two phase 3 studies that showed nebulized Tyvaso demonstrated "statistically significant superiority" over placebo, the company said. United Therapeutics said it expects the FDA to complete its review of the application in late April 2027.