US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies

(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 currently approved CAR-T cell immunotherapies. REMS is required by the FDA to ensure a drug's benefits outweigh its risks by managing serious safety concerns. The FDA said risks linked to CAR-T cell