Observers are waiting to see how the FDA approaches CAR-T therapy safety risks following recently added black box warnings about new cancers.
Tag Archives: Carvykti
Genetic sequencing appears to confirm that some cases of cancer have a direct connection to CAR-T cell transgenes used in the medications, the FDA reports.
Cancerous tumors can develop within weeks after receiving CAR-T drug infusions, some of which can be fatal, the FDA warns.
Clinical studies and post-marketing surveillance has linked side effects of Carvykti to a more than 10% increased risk of blood cancer.
Findings of new report come as FDA is reviewing potential CAR-T cell treatment side effects, amid reports of secondary cancers among patients with aggressive blood cancer.
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A federal judge has ordered Bard hernia mesh settlement negotiations to begin early next month, with the hopes of reaching a global resolution to the claims by late May.
A court-appointed mediator will update a U.S. District Judge on the status of Philips CPAP settlement negotiations for personal injury claims on Friday.
The U.S. JPML has ordered reservoir defect claims to be included in the Bard PowerPort lawsuit multidistrict litigation, over the manufacturers' objections.