July 12, 2022
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.
September 29, 2020
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.
September 22, 2020
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.
August 03, 2020
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.
June 12, 2019
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.