In a move that could dramatically expand access to a revolutionary new treatment, the Food and Drug Administration (FDA) has eliminated some of the safety restrictions for CAR T-cell therapies. This ...
When CAR T-therapies first reached the market, they came with warnings and monitoring requirements to protect patients — for good reason. Engineering a patient’s own immune cells into targeted cancer ...
The departure of the US Food and Drug Administration’s (FDA) cell and gene therapy director and deputy director fuels ongoing turbulence in the treatment modality’s sector and could lead to changes in ...
FDA-approved updates for Breyanzi and Abecma reduce patient monitoring and eliminate REMS, enhancing access to CAR T-cell therapies. Labeling changes reflect increased regulatory confidence in the ...
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. The FDA has removed the Risk Evaluation and ...
Leaders from the world of cell and gene therapy, including molecular geneticists, immunotherapists, physicians, nonprofit directors, and patient advocates, shared their personal stories and policy ...
Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...
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