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Learn about new approvals and the state of the field for each quarter of 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.
In Q2, six new therapies were approved, including two gene therapies that are the first to be approved for their respective indications.
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.
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.
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