United Therapeutics' Ralinepag NDA Accepted by FDA for Pulmonary Arterial Hypertension
United Therapeutics Corporation announced that the FDA has accepted its New Drug Application (NDA) for ralinepag, an investigational once-daily oral prostacyclin for pulmonary arterial hypertension (PAH). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 24, 2027. This acceptance marks a significant step towards potential market approval for a new PAH treatment.
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