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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 ex-vivo CRISPR/Cas9 engineered Wilms¿ tumor 1-specific T-cell receptor T cells
Date Designated: 03/09/2022
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/08/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Intellia Therapeutics, Inc.
40 Erie Street
Cambridge, Massachusetts 02139
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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