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US FDA seeks 'boxed warning' for CAR-T cancer therapies

US FDA seeks 'boxed warning' for CAR-T cancer therapies
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USFDA asks companies to add 'boxed warning' for CAR-T cancer therapies - Pharma News

USFDA asks companies to add 'boxed warning' for CAR-T cancer therapies - Pharma News
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Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe
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US FDA investigating safety risk of CAR-T cancer therapies

The U.S. Food and Drug Administration said on Tuesday it was investigating cancer therapies made by Gilead Sciences, Johnson & Johnson, Novartis and others over the risk of hospitalizations and.

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US FDA investigating safety risk of CAR-T cancer therapies

(Reuters) -The U.S. Food and Drug Administration (FDA) said on Tuesday it was investigating cancer therapies made by companies such as Gilead Sciences, Johnson & Johnson and Novartis over the risk of hospitalizations and death due to a serious safety issue. The FDA said it had received reports of T-cell malignancies, which refer to a group of blood disorders including lymphomas and leukemias, after treatment with CAR-T therapies or chimeric antigen receptor T-cell therapies. Since 2017, six CAR T-cell therapies have been approved by the FDA and all are for the treatment of blood cancers, including lymphomas and some forms of leukemia.

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