After Catalyst Case, FDA Won't Stop Approving Orphan Drugs

By Adam Lidgett · January 23, 2023, 5:34 PM EST

The U.S. Food and Drug Administration has said a loss in litigation involving a treatment for a rare autoimmune disease won't stop it from approving new orphan drugs if they have...

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Case Information

Case Title

Catalyst Pharmaceuticals, Inc. v. Xavier Becerra, et al

Case Number

20-13922

Court

Appellate - 11th Circuit

Nature of Suit

2899 Adminstrative Review Act

Date Filed

October 20, 2020