Vanda Pharmaceuticals, Inc., Petitioner v. Food and Drug Administration, et al.

  1. November 17, 2025

    No High Court Review For FDA Fast-Track Denial

    The U.S. Supreme Court on Monday said it would not consider whether federal drug regulators went astray in denying fast-track review for a digestive disorder medication being developed by Vanda Pharmaceuticals.

  2. May 22, 2025

    Justices Urged To Undo Denial Of Fast Track For Gastro Drug

    Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."