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

The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed warnings for cytokine release syndrome and neurologica ...

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

The FDA has loosened safety restrictions for six CAR T-cell immunotherapies, used in treating a number of blood cancers.

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

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

Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel ...

The REMS, originally designed to reduce the risk of clozapine-related neutropenia, has instead created substantial and avoidable barriers to basic care. As part of this REMS program, ...

Under the REMS program, hospitals and clinics had to be be specially certified to be able to administer CAR-T therapies. Now, though, the FDA has determined that the demand is no longer necessary ...

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