Volumetric PET biomarkers may help predict risk of toxicity from CAR T-cell therapy in patients with large B-cell lymphoma, ...

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

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

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.

Bristol-Myers Squibb's rocky year didn't stop it from joining the Russell 3000 Growth Index, signaling long-term investor ...

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 ...

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

The agency stated that REMS requirements can be removed because safety and effectiveness are assured without them.

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.