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

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

The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) for approved chimeric antigen receptor (CAR) T-cell therapies for hematologic malignancies, aiming to ease provider burden and ...

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

The FDA has removed the REMS program requirement for currently approved BCMA- and CD19-directed autologous CAR T-cell therapies.

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

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

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

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

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

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