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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: transforming growth factor beta trap/anti-programmed death ligand-1 antibody bifunctional fusion protein
Date Designated: 12/07/2018
Orphan Designation: Treatment of biliary tract cancer
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/12/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
EMD Serono Research & Development Institute, Inc.
45 Middlesex Turnpike
Billerica, Massachusetts 01821
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.