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  1. Development & Approval Process (CBER)

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.

2022 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
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
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


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