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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Human induced pluripotent stem cells (iPSC)-derived Photoreceptor Progenitor Cells
Date Designated: 03/20/2024
Orphan Designation: Treatment of Retinitis Pigmentosa
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
iRegene Therapeutics Co., Ltd
Room 301, Building 5, No. 9, 3rd Gao Ke Yuan Road
Precision Medicine Industrial Park, East Lake High-Tech Development Zone
Wuhan, Hubei 430074
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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