News FDA set to raise bar for clinical trials of CAR-T therapies The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.
News FDA backs first AI tool for use in trials, targeting MASH The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with MASH to help measure disease activity.
News ASH: Jaypirca matches Imbruvica in first-line CLL trial Eli Lilly has revealed the data it hopes will take BTK inhibitor Jaypirca into frontline use for chronic lymphocytic leukaemia.
News ASH: FDA okays Gamida aplastic anaemia therapy as data drops The first cell therapy for severe aplastic anaemia – Gamida Cell's Omisirge – has been approved by the FDA.
News ASH: Gilead preps filing for anito-cel on iMMagine-1 data Gilead's Kite unit has showcased three new CAR-T therapies at ASH, headed by multiple myeloma candidate anito-cel, which could launch next year.
News ASH: Regeneron makes frontline case for Lynozyfic in myeloma Regeneron's BCMAxCD3 bispecific Lynozyfic is the first drug in the class to show efficacy as a monotherapy in first-line multiple myeloma.
News Kyverna rises on stiff person syndrome data Kyverna hopes to file CAR-T therapy miv-cell for approval as the first therapy for stiff person syndrome, a rare and debilitating autoimmune disease.
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