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United Therapeutics submits FDA NDA for PAH drug ralinepag

UTHR•2026-08-28

FDA filing for ralinepag and treprostinil

United Therapeutics submitted an FDA New Drug Application in June 2026 for ralinepag to treat pulmonary arterial hypertension.

An FDA supplemental New Drug Application was also filed for nebulized treprostinil to treat idiopathic pulmonary fibrosis.

Ralinepag remains investigational. Nebulized treprostinil remains investigational for idiopathic pulmonary fibrosis.

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United Therapeutics submits FDA NDA for PAH drug ralinepag - UTHR News | Rallies