FDA Accepts New Drug Application for Ralinepag to Treat Pulmonary Arterial Hypertension

The U.S. FDA has accepted United Therapeutics Corporation's New Drug Application for ralinepag, an investigational once-daily oral treatment for pulmonary arterial hypertension (PAH). The agency set a Prescription Drug User Fee Act target action date of June 24, 2027. This regulatory milestone follows positive Phase 3 data, which showed ralinepag significantly reduced the risk of clinical worsening in PAH patients.