The agency is considering further regulatory action after a second Duchenne patient died from acute liver failure less than two months after receiving the gene therapy.

The firm will evaluate VS-7375 as both monotherapy and in combination with Eli Lilly's EGFR inhibitor Erbitux in the study.

The firm is evaluating two dose levels of its nectin-4-targeted ADC plus Merck's Keytruda in a range of solid tumors.

The firm hopes to overcome common dose-limiting toxicities with its PSMA-targeted radiotherapy while boosting potency versus competitors.

In a Phase I study, previously treated pediatric SMA patients exhibited reductions in a marker of neurodegeneration after salanersen treatment.

UCLA-led investigators say additional research is needed into why guideline-recommended genetic testing remains low among ...

In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.

The funding will support the development of Revolution's RAS(ON) inhibitor daraxonrasib in exchange for tiered royalties on its sales.

In the NEULARK trial, patients with early-stage LRRK2-driven Parkinson's disease will receive Neuron23's NEU-411 or a placebo.

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

The agency granted the accelerated approval for Datroway in EGFR-mutant NSCLC based on data from the TROPION-Lung05 and TROPION-Lung01 trials.

Top-line results from a Phase III trial showed an overall survival benefit for zanzalintinib combo therapy in microsatellite-stable colorectal cancer.