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

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

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 ...

The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies ...

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

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

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 ...

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

The thriving Chapel Arts Creative Writing Group, which includes award-winning published writers, will present two shows entitled 800 Years and Counting at Rems Cafe Bar & Restaurant in the town.

The FDA has approved updated labels for Breyanzi and Abecma, removing the REMS programs and reducing certain restrictions.

The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation Strategies (REMS) requirement for ...