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

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 ...

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 ...

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

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

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 ...

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

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

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