Women have been drugged by partners to force abortions. And the pill is routinely used to force victims of sex trafficking to ...

From FDA approvals streamlining access to critical therapies to new breakthroughs in challenging malignancies, the field of cancer care continues to demonstrate remarkable progress.

The agency stated that REMS requirements can be removed because safety and effectiveness are assured without them.

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 ...

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

The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies ...

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

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

EconoTimes is a global, independent publication that delivers comprehensive news, analysis, and insights on the economy, finance, and markets. Based in Korea, we offer a unique perspective on global ...

The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) for approved chimeric antigen receptor (CAR) T-cell therapies for hematologic malignancies, aiming to ease provider burden and ...

EconoTimes is a global, independent publication that delivers comprehensive news, analysis, and insights on the economy, finance, and markets. Based in Korea, we offer a unique perspective on global ...