2022 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 in reverse chronological order.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| CARVYKTI ciltacabtagene autoleucel |
Is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. | 125746/0 | Janssen Biotech, Inc. 920 US Highway 202 P.O. Box 300 Raritan, NJ 08869 Lic. # 1864 |
02/28/2022 |
| SPIKEVAX COVID-19 Vaccine, mRNA |
Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | 125752/0 | ModernaTX, Inc. 200 Technology Square Cambridge, MA 02139 Lic. # 2256 |
01/31/2022 |