Over the past decade, CAR-T cell therapies have revolutionized the field of cell therapy, demonstrating clear curative potential with autologous approaches. Now, the field is looking to take these treatments a step further, by delivering next generation products that are cheaper, safer, and more efficacious. [Read more…]

While there has been a consistent stream of RMAT approvals since the designation was created in 2017, with 60 publicly announced to date, the number of approvals in the first few days in 2022 are noteworthy. Specifically, from January 1 to January 18, 2022, four companies publicly announced RMAT designations, as described below.

An RMAT designation is an award from the U.S. FDA that allows for faster, more streamlined approvals of regenerative medicine products within the United States, such as cell and gene therapies, tissue engineering products, and combination products. RMAT designations make innovative products eligible for quicker development and review of a marketing application. [Read more…]