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

Source: zacks.com

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

United Therapeutics received FDA acceptance for a Tyvaso sNDA seeking an IPF label expansion, supported by TETON data showing improved lung function and reduced clinical worsening. The regulatory milestone supports the probability of incremental revenue from a broader approved indication, with positive implications for the near-term clinical/commercial outlook.

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