FDA Demands "Boxed Warning" to CAR T-Cell Therapy Labels
The FDA has asked Gilead Sciences, Inc. (GILD) , Johnson & Johnson (JNJ) and Novartis (NVS) to add “boxed warning” to the labels of their chimeric antigen receptor (CAR) T-cell immunotherapies, per Reuters.The regulatory body sent letters to these companies stating that it had identified adverse events and clinical trial reports describing T-cell malignancies.We remind readers that in November 2023, the FDA announced that it was investigating the identified risk of T-cell malignancy in patients who received ...