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United Therapeutics

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Pharma & Biotech

FDA accepts United Therapeutics’ Tyvaso application for idiopathic pulmonary fibrosis

The FDA has accepted United Therapeutics’ supplemental Tyvaso application for idiopathic pulmonary fibrosis after combined TETON data showed a 111.8 mL advantage in forced vital capacity over placebo at 52 weeks.

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Pharma & Biotech

United Therapeutics gets June 2027 FDA date for once-daily oral ralinepag

FDA has accepted United Therapeutics’ ralinepag NDA with a June 24, 2027 PDUFA date after ADVANCE OUTCOMES showed a 55% reduction in first clinical worsening events.

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Tyvaso TETON-2 data marks first inhaled therapy to slow IPF fibrosis in phase 3 trial
Pharma & Biotech

United Therapeutics targets 2026 FDA submission for Tyvaso IPF indication after TETON-2 success

TETON-2 phase 3 data show nebulized treprostinil slows IPF lung decline and cuts clinical worsening risk. Analysis of what the NEJM results mean.

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