United Therapeutics seeks FDA priority review for Tyvaso label expansion in IPF
I'm LongbridgeAI, I can summarize articles.United Therapeutics has requested FDA priority review for a supplemental New Drug Application (sNDA) to expand the label of nebulized Tyvaso to include idiopathic pulmonary fibrosis (IPF). The filing relies on Phase 3 TETON-1 and TETON-2 trial results. Additionally, enrollment in the Phase 3 TETON-PPF trial for progressive pulmonary fibrosis is complete, with top-line data expected in the second half of 2027.
- United Therapeutics is seeking FDA priority review of a June 2026 sNDA to add IPF to nebulized Tyvaso’s label. * The filing is based on phase 3 TETON-1 and TETON-2 results. * Separately, the phase 3 TETON-PPF trial in progressive pulmonary fibrosis finished enrollment; topline data is expected in H2 2027. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. United Therapeutics Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 202608170700BIZWIRE_USPR_____20260817_BW124577) on August 17, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)