October 10, 2025 at 11:04PM FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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