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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: chimeric antigen receptor (CAR) modified recombinant T cells targeting B7-H3
Date Designated: 06/21/2023
Orphan Designation: Treatment of Malignant Glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Fuzhou Tcelltech Biological Science and Technology Inc.
Haixi High-Tech Industrial Zone
Room A-504, Building 10, Innovation Park
Fuzhou, Fujian 350108
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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