United Therapeutics says FDA accepts ralinepag NDA for pulmonary arterial hypertension
UTHR•FDA accepts ralinepag NDA
- 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.
