Soleno Therapeutics (SLNO) announced that the U.S. Food and Drug Administration, FDA, has extended the review period for the New Drug Application, NDA, for DCCR extended-release tablets for the treatment of Prader-Willi syndrome, PWS, in individuals four years and older who have hyperphagia. The new Prescription Drug User Fee Act, PDUFA, target action date is March 27, 2025.
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