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

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

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

US FDA approves label updates for Bristol Myers’ CAR T cell therapies, Breyanzi for LBCL & lymphomas and Abecma for multiple myeloma: Princeton, New Jersey Saturday, June 28, 20 ...

Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved label updates for ...

Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell therapies. Read more here.

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

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

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

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