REDWOOD CITY, Calif., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ('Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a regulatory update from the U.S. Food and Drug Administration (FDA).
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 (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS). However, the Division's review team will continue to consider the potential need for an advisory committee meeting during their ongoing review.