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Learn about new approvals and the state of the field for each quarter of 2024.
The field earned the approval of three new therapies—a CAR-T therapy for myeloma in China, an AAV gene therapy for hemophilia B in Canada, and an autologous cell therapy for melanoma in the United States.
In Q2, two new RNA therapies were approved in the US; Rytelo was approved for myelodysplastic syndrome and mRESVIA, an mRNA vaccine, was approved for respiratory syncytial virus (RSV) prophylaxis.
While we saw only one new approval (Tecelra for synovial sarcoma), there are dynamic shifts deeper in the pipeline. The field is steadily diversifying; 51% of newly initiated gene therapy trials are now for non-oncology indications, up from just 39% year-over-year.
We saw approvals across three modalities in Q4: Aucatzyl for acute lymphocytic leukemia, RegeneCyte for blood disorders, and Tryngolza for lipoprotein lipase deficiency
May 13-17, 2025 | New Orleans
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