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

Bristol Myers' legacy drug sales plunged 20% amid generic erosion and Medicare changes, spotlighting its shift to a newer growth portfolio.

Lynozyfic (linvoseltamab) has been given accelerated approval by the US regulator for adults with relapsed or refractory ...

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 ...

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 ...

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

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