Soleno Therapeutics announced a regulatory update from the U.S. Food and Drug Administration. The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application for DCCR extended-release tablets for the treatment of Prader-Willi syndrome. However, the Division’s review team will continue to consider the potential need for an advisory committee meeting during their ongoing review. As announced previously, the DCCR NDA was designated for Priority Review with a Prescription Drug User Fee Act target action date of December 27, 2024.
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