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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.
The firm is hoping to show in studies that its test can identify prostate cancer patients at low risk of recurrence who can receive less aggressive therapy.
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 ...