2023 Archive

Read and Download 2023 Reports

Learn about new approvals and the state of the field for each quarter of 2023.

Q1 2023

In the first quarter, an mRNA vaccine was approved for COVID-19 prophylaxis in China; Vyznova, a non-genetically modified cell therapy, was approved for corneal dystrophy in Japan; and Hemgenix was approved for hemophilia B in the EU and UK.

 

Q2 2023

In Q2, six new therapies were approved, including two gene therapies that are the first to be approved for their respective indications.

 

Q3 2023

In Q3, an anti-BCMA-targeting CAR T-cell therapy, Fucaso, was approved for multiple myeloma in China and an mRNA vaccine, Daichirona, was approved for COVID-19 in Japan.

Q4 2023

In the final quarter of 2023, FDA approved two cell-based gene therapies, Casgevy and Lyfgenia, to treat sickle cell disease. Casgevy represents the first-ever approval for a CRISPR-based therapeutic in the United States.

2025

Class Considerations on Immunogenicity for AAV GT Products

January 22-23, 2025 | Virtual

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