FDA Accepts United Therapeutics' Ralinepag Application for Pulmonary Arterial Hypertension

United Therapeutics' New Drug Application for ralinepag, an investigational treatment for pulmonary arterial hypertension (PAH), has been accepted by the FDA. The application, supported by positive Phase 3 ADVANCE OUTCOMES study results showing reduced clinical worsening, has a PDUFA target action date of June 24, 2027.