Cell Therapy News

The FDA granted rare pediatric disease designation to EDIT-301, an investigational autologous cell therapy for the treatment of sickle cell disease, according to the agent’s manufacturer.

The FDA has approved Kesimpta, the first self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis, the manufacturer announced.

The FDA granted fast track designation to PBCAR0191, a chimeric antigen receptor T-cell therapy for treatment of advanced B-cell precursor acute lymphoblastic leukemia, according to the agent’s manufacturer.

Patrick Hwu, MD, has been appointed president and CEO of Moffitt Cancer Center.

A new prognostic tool has been developed to help clinicians predict which patients may experience neurotoxic effects of chimeric antigen receptor T-cell therapy, according to a study published in JAMA Neurology.

An FDA advisory committee voted 9-1 in favor of approval of the cell therapy remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

The FDA approval of brexucabtagene autoleucel represents a major step forward for the treatment of adults with relapsed or refractory mantle cell lymphoma, experts told Healio.

The FDA cleared an investigational new drug application for AGT103-T, an autologous, genetically modified cell therapy for the treatment of HIV, according to the agent’s manufacturer.

The National Comprehensive Cancer Network published the latest in its series of guidelines intended to inform patients and their caregivers about adverse events associated with cancer therapies.

In patients with MI, reduced left ventricular ejection fraction and large LV scar size, cardiosphere-derived cells did not reduce scar size but lowered LV volume and levels of a key biomarker, according to results of the ALLSTAR trial.