FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.
Recommend0 recommendationsPublished in US National Health Agency Sources