In recent years, the FDA has communicated a focus on advancing the development of cell and gene therapies (CGT), mirroring industry’s optimism that these therapies have the potential to offer durable and targeted treatment options. FDA’s attention to CGTs is reflected in the pace of approvals in 2024, with eight novel CGTs and at least six new indications for existing CGTs approved over the course of the year. It is important to note, however, that even as FDA’s pace of approvals appears to be increasing, the Agency continues to be highly focused on the safety of these products throughout the development process.
In this article, we recap the significant FDA regulatory considerations for CGTs in 2024 and offer a preview of potential developments for 2025.
View article here.
