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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: FGFR3 targeting antibody-drug conjugate
Date Designated: 02/13/2025
Orphan Designation: treatment of glioblastoma, glioma (harboring the FGFR3-TACC3 fusion)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biohaven Therapeutics Ltd.
P.O. Box 173
Kingstown Chambers, Town Road
Tortola VG1110
Virgin Islands, British

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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