NEW YORK – Carsgen Therapeutics on Monday said it plans to seek approval in China for its autologous CAR T-cell therapy satricabtagene autoleucel (satri-cel) in previously treated patients with ...

The FDA granted priority review to the company's avutometinib-defactinib application and expects to decide on approval in June 2025.

Regulators approved the first bespoke cell therapies for solid tumors this year, while drugmakers expanded and improved upon ...

Sangamo is seeking new partners to continue advancing giroctocogene fitelparvovec, which reported positive Phase III results this year.

Concr will use data collected by CariGenetics to create AI models to advance precision medicine for triple-negative breast cancer patients in the Caribbean.

The firm said it plans to share data with regulatory agencies from the Phase III STEER trial after it met its primary endpoint.

To be eligible for the firm's half-life extended ImmTAC therapy, patients must be HLA-A*02:01-positive and have advanced solid cancers expressing PRAME.

The decision follows a similar one in the US and is due to the drug's failure to significantly improve overall survival versus chemo in the TROPION-Lung01 trial.

The firm, which launched earlier this year, will use the funds to grow its operations and advance its gene therapy programs.

Precision Medicine Online readers were interested in stories about implementation challenges in the space, the first cell therapies for solid tumors, and cardiovascular drugs targeting Lp(a).

NEW YORK – The US Food and Drug Administration has accepted Nuvation Bio's new drug application (NDA) seeking approval for taletrectinib as a line-agnostic treatment for advanced ROS1-positive ...

The transaction, expected to close in the first half of 2025, will not affect the firm's other contract research business units.