BE-101 is an engineered B-cell therapy, in which a functional copy of the FIX gene is inserted into patients' own B cells in vivo.

The partners will seek CAP/CLIA certification for an organoid-based assay and conduct clinical validation studies of it as a tool to guide treatment.

NEW YORK – ARTBio this week said it has raised $132 million in Series B financing to advance its alpha radioligand therapies and bolster the supply chain underlying their development.

Experts don't back specific tests, but provide guidelines on how doctors in specialty care settings can use them to diagnose ...

As Keytruda generic competition looms larger on the horizon, the company is hoping to reinvest the savings into pipeline ...

Neurologists from multiple clinics shared data at AAIC on the Alzheimer's drug's use, shedding light on its safety and ...

The agency previously declined to approve Atara's first Ebvallo biologics license application, but has accepted a data package it resubmitted this month.

Trontinemab is a formulation of Roche's failed gantenerumab but now paired with the company's Brainshuttle technology to ...

The therapies, which are just starting to enter clinical trials, will need to prove clear clinical and quality-of-life ...

Despite regulatory setbacks, the petitioners believe that survival and other data they've collected themselves are worth ...

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

The firm will retain rights to its preclinical assets including two T-cell receptor T-cell therapies and its allogenic program.