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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mRNA encoding the human CFTR protein
Date Designated: 04/21/2026
Orphan Designation: treatment of cystic fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BodMed Co., Ltd.
Biomedical Industrial Park 1, No. 218 Xinghu Road, Industrial Park
Room 419/420, Building 4, Zone A
Suzhou City, Jiangsu Province 215123
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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