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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous anti-CD19 CAR T cell immunotherapy
Date Designated: 04/24/2024
Orphan Designation: treatment of myasthenia gravis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kyverna Therapeutics, Inc.
5980 Horton Street, Suite 200
Emeryville, California 94608
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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