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VANDA PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION et al

  1. August 02, 2023

    FDA Snags Early Win In Vanda Gastro Drug Review Challenge

    A District of Columbia federal judge has entered judgment in favor of the U.S. Food and Drug Administration in Vanda Pharmaceuticals' suit challenging the agency's refusal to streamline review of a drug meant to treat nausea in patients with a chronic gastric condition, according to an order issued Wednesday.

  2. January 11, 2023

    Judge Pushes Resolution In Vanda, FDA Gastro Drug Fight

    A D.C. federal judge on Wednesday said Vanda Pharmaceuticals Inc. and the U.S. Food and Drug Administration seemed to be arguing past each other in a case challenging the FDA's rejection of the company's anti-nausea drug for patients with a chronic gastric condition and suggested the dispute could be resolved if Vanda submitted a new, revised application.

  3. May 23, 2022

    Vanda Fights FDA's Refusal To Fast-Track Gastro Drug Review

    Vanda Pharmaceuticals says the U.S. Food and Drug Administration tried to rewrite the law when it chose not to streamline review of a drug meant to fight nausea in patients with a chronic gastric condition.