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United Therapeutics says FDA accepts ralinepag NDA for pulmonary arterial hypertension

PUBT·08/24/2026 11:00:58
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United Therapeutics says FDA accepts ralinepag NDA for pulmonary arterial hypertension
  • FDA accepted United Therapeutics’ NDA for ralinepag to treat pulmonary arterial hypertension.
  • PDUFA target action date set for June 24, 2027.
  • Phase 3 ADVANCE OUTCOMES showed a 55% reduction in clinical worsening risk versus placebo.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. United Therapeutics Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 202608240700BIZWIRE_USPR_____20260824_BW016096) on August 24, 2026, and is solely responsible for the information contained therein.