FDA Accepts UTHR's sNDA for Tyvaso in Idiopathic Pulmonary Fibrosis

United Therapeutics announced FDA acceptance of a supplemental new drug application for nebulized Tyvaso to treat idiopathic pulmonary fibrosis (IPF), with a regulatory decision expected in late April 2027. The TETON phase III studies demonstrated statistically significant improvements in lung function, including a 111.8 mL FVC benefit, reduced clinical worsening, and favorable secondary endpoints. If approved, Tyvaso would be the first FDA-approved inhaled anti-fibrotic treatment for IPF.