The approval was based on results from the Phase II HORIZON-Lung trial, in which the treatment had a median progression-free survival of 11.5 months.

The firm submitted data showing that more than 70 percent of patients with HER2-mutated NSCLC who hadn't received anti-HER2 therapy responded to sevabertinib.

The approval was based on results from the Phase II HORIZON-Lung trial, in which the treatment had a median progression-free survival of 11.5 months.

Drugmakers are turning to biomarkers, like folate receptor alpha, and even cell therapies to tackle this deadly cancer in new ...

The firm will study AKY-1189 in Nectin-4-expressing tumors, including urothelial and triple-negative breast cancer.

Taysha expects to initiate the pivotal study, which will be part B of an ongoing Phase I/II trial, of TSHA-102 in the third quarter.

The biotech startup, a spinout of the University of Colorado Anschutz Medical Campus, launched this year with $15 million in ...

Regulators will review data on satri-cel's ability to treat advanced Claudin18.2-positive tumors in an expedited timeline.

The firm will use the proceeds from the private placement to advance its clinical-stage cardiomyopathy gene therapy programs.

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Autolus Therapeutics' autologous CD19-directed CAR T-cell therapy Aucatzyl ...

The firm has inked a debt financing agreement with Blue Owl Capital and will use the funds to launch ITM-11in the US market following approval.

Located at the system's hospital in St. George, Utah, the clinic intends to offer T-cell collection closer to home.