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

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.

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 ...

Shares of this biotech giant have lost 16.3% year to date compared with the industry’s decline of 2.7%. The sto ...

A novel chimeric antigen receptor T-cell therapy may benefit patients with B-cell lymphomas who previously relapsed following ...

The FDA has removed risk evaluation and mitigation strategies for CAR-T cell therapies, streamlining treatment for blood ...

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

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

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 ...