2026 Biological License Application Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number | Approval Date |
|---|---|---|---|---|
allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq | Indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versushost disease (cGVHD)-free survival, in the treatment of adults with hematological malignancies. | 125868/0 | Orca Biosystems Inc. 3475 Edison Way, Suite C Lic. # 2404
| 06/30/2026 |
lunsotogene parvec-cwha | Indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. | 125874/0 | Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Rd Lic. # 1760 | 04/23/2026 |
marnetegragene autotemcel | Indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. | 125806/0 | Rocket Pharmaceuticals, Inc. 9 Cedarbrook Drive Lic. # 2328 | 03/26/2026 |
| Procleix Plasmodium Assay Procleix Plasmodium Assay | Intended for use in screening individual human donors, including donors of whole blood and blood components, and in screening living donors of organ and tissue samples when specimens are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. Whole blood donor samples are tested individually. | 125862/0 | Grifols Diagnostic Solutions, Inc. 10804 Willow Court San Diego, CA 92127 Lic. # 2032 | 03/16/2026 |