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.
Human Drugs
PhRMA Wants More Feedback on Innovative Trials
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.