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 |
|---|---|---|---|---|
| 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 |