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 ...

Since the first-generation CAR-Ts reached the market several years ago, clinicians have become more adept at handling ...

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; ...

FDA eliminated REMS for six approved CAR-T therapies. Patients no longer need to stay near treatment site for two weeks or avoid driving post-therapy. Market-moving news hits Benzinga Pro first—get a ...

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

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

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

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

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

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