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 ...
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 MarketWatch News Department was not involved in the creation of this content. White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is sharing ...
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 ...
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...
Cellares, which last year became the first company to receive the FDA's new advanced manufacturing technology designation, ...
The U.S. Food and Drug Administration (FDA) recently issued three draft guidances concerning development of cell and gene therapy (CGT) products. The guidances provide advice concerning qualifying ...
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