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United Therapeutics seeks FDA priority review for Tyvaso label expansion in IPF

PUBT·08/17/2026 11:00:58
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United Therapeutics seeks FDA priority review for Tyvaso label expansion in IPF
  • 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.