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

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 ...

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

Bristol Myers’ BMY legacy portfolio comprises Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane. Revenues for the Legacy ...

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

Bristol Myers Squibb has announced that the FDA has given approval to label updates for Breyanzi and Abecma to treat multiple myeloma.

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 U.S. Food and Drug Administration (USFDA) has announced that it has eliminated the Risk Evaluation and Mitigation ...