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

The FDA has removed the REMS program requirements for embryofetal toxicity risk from all endothelin receptor antagonist medications.

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

(Reuters) -The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a safety program to protect patients from risky drugs, for ...

10th Risk Evaluation & Mitigation Strategies SummitThere is still time to reserve your seat for the 10th REMS Summit! Convening January 29–30 in Arlington, VA, professionals from pharma, FDA ...

FDA CAR-T Therapies: The FDA has removed risk evaluation and mitigation strategies for CAR-T cell therapies, streamlining treatment for blood cancers while emphasizing existing safety ...

The FDA has removed the REMS program requirement for currently approved BCMA- and CD19-directed autologous CAR T-cell therapies.

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...

George Mulligan, PhD, previews the FDA's ODAC meeting discussing the application of belantamab mafodotin-based combinations for the treatment of multiple myeloma.