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

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.

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.

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

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

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 ...

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 ...

NEW YORK – Bristol Myers Squibb on Monday said the European Commission approved its PD-1 inhibitor Opdivo (nivolumab) plus the CTLA-4 inhibitor Yervoy (ipilimumab) as a first-line treatment for ...