News

The University of Alabama at Birmingham1h
Scientists uncover new approach for targeting aggressive breast cancer
In 2022, there were 2.3 million women diagnosed with breast cancer and 670,000 deaths worldwide, according to the World ...
US FDA Eliminates Risk Evaluation and Mitigation Strategies for CAR-T Cancer Therapies
(Reuters) -The U.S. Food and Drug Administration said on Friday that it had eliminated the risk evaluation and mitigation ...
Precision Medicine Online3h
FDA Removes REMS Programs for BMS's Breyanzi, Abecma CAR T-Cell Therapies
The agency will allow BMS to discontinue REMS programs for both therapies and reduce certain patient monitoring requirements.
Bristol Myers, Gilead, J&J, Novartis win favorable FDA label updates for cell therapies
Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...
BioPharma Dive5h
FDA takes major step to ease access to CAR-T therapy
The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...
PharmExec5h
FDA Approves Label Updates for BMS' Breyanzi, Abecma in Lymphoma, Myeloma
Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader ...
CURE6h
FDA Approves CAR T Therapy Label Updates Across Various Blood Cancers
Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...
MPR6h
FDA Removes REMS, Reduces Monitoring Requirements For Breyanzi and Abecma
The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
FDA Eases Rules For Bristol Myers' Cell Therapies For Blood Cancers
FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...
Fierce Pharma7h
FDA removes CAR-T access barrier in move set to boost cancer immunotherapy uptake
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. | The FDA has removed the REMS requirements for ...
Health Affairs9hOpinion
Congress Should Remove The Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It
Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs ...