FDA accepts United Therapeutics' ralinepag NDA for PAH

The US FDA has accepted United Therapeutics' New Drug Application for ralinepag, an oral prostacyclin IP receptor agonist for pulmonary arterial hypertension, with a PDUFA target action date of June 24, 2027. The approval would introduce the first once-daily oral option in its class, competing with existing multi-dose prostacyclin therapies and recent activin pathway treatments.

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