Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings
Fierce Pharma
JANUARY 24, 2024
The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, it's adjusted the wording of a proposed boxed warning.
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