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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: reversible, adenosine triphosphate (ATP) competitive inhibitor of ERK1/2
Date Designated: 08/27/2026
Orphan Designation: treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biomed Valley Discoveries Inc.
4435 Main Street, Suite 550
Kansas City, Missouri 64111
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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