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

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.

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 ...

NEW YORK – Viracta Therapeutics last week said it was closing a pivotal Phase II trial of nana-val and exploring strategic alternatives to conserve its resources. In the NAVAL-1 trial, San Diego-based ...

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

Alyftrek is approved as a new treatment for cystic fibrosis, while the FDA expanded the label for Trikafta to include additional genetic mutations.

NEW YORK – 2024 was a banner year of "firsts" in the gene therapy space, as the US Food and Drug Administration greenlit ...

NEW YORK – AstraZeneca on Monday said the European Commission approved its tyrosine kinase inhibitor Tagrisso (osimertinib) as a treatment for patients with advanced, unresectable non-small cell lung ...

The drug combo is the first dual checkpoint inhibitor therapy approved in Europe for first-line metastatic MSI-H or dMMR colorectal cancer.