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With immunotherapy increasingly making it out of the lab and into hospitals as a viable way to treat serious conditions like ...
During a live event, Priyanka Pophali, MD, MBBS, discussed CAR T-cell therapy referrals, timing, and challenges in relapsed ...
US FDA eliminates REMS for autologous chimeric antigen receptor CAR T cell immunotherapies: Maryland Monday, June 30, 2025, 13:00 Hrs [IST] The US Food and Drug Administration (FD ...
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 ...
The FDA has removed the REMS program requirement for currently approved BCMA- and CD19-directed autologous CAR T-cell therapies.
A team of researchers led by NYU Tandon School of Engineering's Weiqiang Chen has developed a miniature device that could ...
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 ...
Oncternal Therapeutics, Inc. today announced the sale of its zilovertamab and ONCT-808 programs to Ho’ola Therapeutics, Inc. Zilovertamab is an investigational monoclonal antibody designed to inhibit ...
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.
AZD0486 demonstrated encouraging safety and dose-dependent efficacy in heavily pretreated adolescent and adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), according to ...
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