2025 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 |
|---|---|---|---|---|
| QIVIGY immune globulin intravenous, human-kthm 10% solution | Indicated for the treatment of adults with primary humoral immunodeficiency. | 125822/0 | Kedrion S.p.A. Lic. # 1851 | 9/26/2025 |
| PAPZIMEOS zopapogene imadenovec-drba | Indicated for the treatment of adults with recurrent respiratory papillomatosis. | 125832/0 | Precigen, Inc. Lic. # 2364 | 8/14/2025 |
| MNEXSPIKE COVID-19 Vaccine, mRNA | Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. | 125835/0 | Moderna TX, Inc. Lic. # 2256 | 5/30/2025 |
| NUVAXOVID COVID-19 Vaccine, Adjuvanted | Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older. Additionally, COVID-19 Vaccine, Adjuvanted is indicated for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. | 125817/0 | Novavax Inc. Lic. # 2349 | 5/16/2025 |
| ZEVASKYN prademagene zamikeracel | Indicated for treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). | 125807/0 | Abeona Therapeutics, Inc. 6555 Carnegie Ave, 4th Floor Cleveland, OH 44103 Lic. # 2329 | 04/28/2025 |
| ENCELTO revakinagene taroretcel-lwey | Indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). | 125798/0 | Neurotech Pharmaceuticals, Inc. 900 Highland Corporate Drive Building #1, Suite #101 Cumberland, RI 02864 Lic. # 2321 | 03/05/2025 |
| VIMKUNYA Chikungunya Vaccine, Recombinant | Indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. | 125820/0 | Bavarian Nordic A/S Bavarian Nordic, Inc. 1005 Slater Road, Suite 101 Durham, NC 27703 Lic. # 2096 | 02/14/2025 |
| PENMENVY Meningococcal Groups A, B, C, W, and Y Vaccine | Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age. | 125819/0 | GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 | 02/14/2025 |
| Automated C3d Plate Anti-Human Globulin (Murine Monoclonal) | Indicated for use on Echo Lumena and Galileo Echo in automated direct antiglobulin tests (DAT) where detection of C3d is required. | 125753/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 Lic. # 0886 | 01/08/2025 |