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 ...

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 ...

The Alliance for Regenerative Medicine has voiced deep disappointment about reports that the FDA has put the director of its cell and gene therapy office on administrative leave and escorted her out ...

The U.S. Food and Drug Administration (FDA) approved label updates for Bristol Myers Squibb & Co.’s (NYSE:BMY) CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) for large B cell ...

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 ...