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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: genetically engineered, replication-competent vesicular stomatitis virus (VSV)-based oncolytic viral therapy
Date Designated: 05/27/2026
Orphan Designation: treatment of hepatoblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Humane Genomics Inc.
430 E 29th Street
Floor 14, Suite 1430
New York City, New York 10016
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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