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The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...
Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and ...
CHICAGO, IL / ACCESS Newswire / July 1, 2025 / The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation ...
The U.S. Food and Drug Administration (USFDA) has announced that it has eliminated the Risk Evaluation and Mitigation ...
Learn how to integrate risk mitigation strategies into organizational policies and operational processes. Review real-world case studies showcasing successful risk assessment and mitigation ...
The FDA has approved updated labels for Breyanzi and Abecma, removing the REMS programs and reducing certain restrictions.
(Reuters) -The U.S. Food and Drug Administration said on Friday that it had eliminated the risk evaluation and mitigation ...
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 ...
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