News

With immunotherapy increasingly making it out of the lab and into hospitals as a viable way to treat serious conditions like ...
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 transform how blood cancer ...
FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.
Multiple myeloma begins when abnormal cells multiply and grow uncontrollably in a person’s bone marrow, crowding out healthy ...
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 ...
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 ...
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 ...
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
The U.S. Food and Drug Administration (FDA) announced on Friday that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous ...
Three major Mount Sinai research studies offer new hope for patients facing chronic lymphocytic leukemia (CLL), a rare type ...
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 ...