There is enough experience with the first wave of autologous CAR-T therapies targeting CD19 and BCMA to allow strict rules ensuring their safe use to be relaxed, according to the FDA. The US regulator ...

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It was only about a year ago that the biopharma industry hailed a decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine ...

Vandetanib's REMS program was removed due to no reported cases of torsades de pointes or sudden deaths. Healthcare providers have successfully integrated heart rhythm safety monitoring into standard ...

The update now reduces the frequency of liver function monitoring to every 3 months from the onset of treatment. The Food and Drug Administration (FDA) has updated the risk evaluation and mitigation ...

In a surprising announcement, the U.S. Department of Education’s Office of Safe and Supportive Schools announced the closure of the Readiness and Emergency Management for Schools (REMS) Technical ...

FDA simplifies liver monitoring schedule from monthly to every three months for the duration of treatment and removes embryo-fetal toxicity REMS monitoring SAN DIEGO, August 27, 2025--(BUSINESS WIRE)- ...

The US Food and Drug Administration (FDA) announced that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric ...

The following products no longer have a REMS requirement: Abecma; Breyanzi; Carvykti; Kymriah; Tecartus; and Yescarta. The Food and Drug Administration (FDA) has removed the Risk Evaluation and ...

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 ...

Bengaluru: 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 ...

When CAR T-therapies first reached the market, they came with warnings and monitoring requirements to protect patients — for good reason. Engineering a patient’s own immune cells into targeted cancer ...