The agency approved the autologous CAR T-cell therapy based on data showing that around 62 percent of patients had no signs of cancer after a single infusion.

In the Phase I portion of the trial, there were no reported serious adverse events and a 100 percent complete response rate at the highest dose level of EB103.

The regimen reduces the steps required to administer tumor-specific antibodies and a radioactive payload to carcinoembryonic antigen-positive tumors.

The company has also received orphan drug, rare pediatric disease, and fast-track designations for LTS-101 as a potential treatment for the fatal neurodegenerative disease.

Trontinemab, designed to reach the brain better than gantenerumab, led to amyloid negativity in 92 percent of patients at the ...

The companies plan to test the treatment's efficacy in preclinical models of squamous cell lung carcinoma early next year.

The firm said treatment with the autologous immunotherapy demonstrated increased overall survival compared to placebo in a Phase II study.

Project GENIE will use the funding to build an AI-based tool to perform multilingual clinical data translation and expand global access to the registry.

The firm received guidance from the FDA during a recent type B meeting on the study's inclusion criteria, design, and statistical parameters.

The agency is proposing that drugmakers use shorter non-rodent studies and other sources of evidence when developing monoclonal antibodies for non-cancer settings.

The nonprofit is focused on access to precision medicine testing and treatment for former Special Operations Forces personnel ...

The study will test the therapy in lung, colorectal, and head and neck cancer patients with B7H3 and PTK7 mutations.