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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 peripheral blood mononuclear cells manipulated ex vivo to produce macrophages with markedly reduced signal-regulatory protein alpha (SIRPalpha) expression
Date Designated: 11/06/2023
Orphan Designation: Treatment of T-cell lymphoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SIRPant Immunotherapeutics
1590 Bunker Court
Chambersburg, Pennsylvania 17202-8040
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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