FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies.

Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to allow more discussion on model-informed drug development, global harmonization, real-world evidence, and novel endpoints, among other issues.