Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain ...

The agency stated that REMS requirements can be removed because safety and effectiveness are assured without them.

The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

FDA officials have determined that information regarding the risks for six CAR T-cell therapies can be communicated through product labeling, which includes a boxed warning for the risks of cytokine ...

Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel ...

Wristband that provides relief for upper limb tremor is approved; FDA warns of clinically significant weight loss in younger kids taking ADHD meds; REMS removed for CAR T-cell immunotherapies; ...

The FDA approved Lynozyfic for relapsed multiple myeloma, but serious risks require restricted use under a special safety ...

The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...