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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Mesenchymal stem cell (MSC) derived small extracellular vesicles (EVs) loaded with short and modified interfering RNA (siRNA) against the phosphatase and tensin homolog (PTEN) protein
Date Designated: 10/26/2023
Orphan Designation: Treatment of Acute Spinal Cord Injury
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
NurExone Biologic, Ltd.
9 Mezada St. BSR 3 Tower, 30 Fl.
Bnei-Brak 5120109

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.