United Therapeutics seeks FDA priority review for Tyvaso label expansion in IPF - UTHR News | RalliesUnited Therapeutics seeks FDA priority review for Tyvaso label expansion in IPF
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UTHR• FDA priority review sought for Tyvaso label expansion
- 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.
Related progressive pulmonary fibrosis trial completed enrollment
- Separately, the phase 3 TETON-PPF trial in progressive pulmonary fibrosis finished enrollment; topline data is expected in H2 2027.
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