CHICAGO, IL / ACCESS Newswire / July 1, 2025 / The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation ...

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 ...

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 ...

Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and ...

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 ...

AbbVie (NYSE: ABBV) and Capstan Therapeutics, Inc. ("Capstan"), a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using tLNPs, today ...

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