Catalyst Pharmaceuticals, Inc. v. Azar et al

  1. July 12, 2022

    Catalyst Inks Deal To End Its 'Orphan Drug' Case

    Florida-based Catalyst Pharmaceuticals Inc. has inked a deal to settle its patent case against a rival involving a drug that treats a rare autoimmune disease, ending litigation that made its way to the U.S. Supreme Court.

  2. September 29, 2020

    Catalyst Loses Fight Against FDA Approval Of Rival's Drug

    A Florida federal judge axed Catalyst Pharmaceuticals Inc.'s suit claiming the U.S. Food and Drug Administration unlawfully approved a lower-cost version of a drug that treats a rare autoimmune disease, rejecting Catalyst's challenge against a magistrate judge's ruling.

  3. September 22, 2020

    Catalyst Says FDA Is Breaking Law By Approving Rival's Drug

    Catalyst Pharmaceuticals Inc. fought Tuesday against a federal judge's determination that the U.S. Food and Drug Administration lawfully approved a lower-cost version of a drug that treats a rare autoimmune disease, arguing that the Orphan Drug Act does not allow the approval of two drugs to treat the same disease.

  4. August 03, 2020

    No Evidence FDA Sabotaged $375K-A-Year Drug, Judge Says

    The U.S. Food and Drug Administration lawfully approved a lower-cost version of a $375,000-per-year drug for a rare autoimmune disease because the agency reasonably interpreted the Orphan Drug Act where it fell short, a federal magistrate judge said.

  5. June 12, 2019

    FDA Flouted Law To Undercut $375K Drug, Suit Says

    The U.S. Food and Drug Administration unlawfully approved a lower-cost version of a $375,000 per year drug for a rare autoimmune disease because of concerns about affordability, according to a lawsuit filed Wednesday in Florida federal court.