Risk has changed. E-waste is not just waste, it is a compliance failure waiting to happen, a data breach in transit, a ...

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

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

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 ...

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

The FDA has eliminated Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, determining that the safety program is no ...

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

The FDA is eliminating of Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed CAR ...

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.

The U.S. Food and Drug Administration (FDA) announced on Friday that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous ...