The firm will evaluate the combination therapy in 80 patients with germline BRCA1/2-mutated HER2-negative locally advanced or metastatic breast cancer.
The VERVE-102 base editor appeared to be safe and reduce low-density lipoprotein cholesterol levels by up to 62 percent in a Phase 1 open-label, single-ascending dose trial.
The task force that makes recommendations on cancer screening, including genetic testing, hasn't met since March 2025 but ...
Datroway gained US approval for first-line TNBC patients while Enhertu was recommended for approval in Europe as a tissue-agnostic treatment for HER2-positive tumors.
The EMA accepted Regeneron's marketing authorization application for the gene therapy and will review it under accelerated assessment.
The partners will stop developing BIIB122 in an all-comer population, but Denali will keep evaluating it in those with LRRK2 pathogenic variants.
The recommendation, based on data from the SERENA-6 trial, breaks from the opinion of an FDA advisory committee last month.
Foundation Medicine previously received companion diagnostic approval for its FoundationOne Liquid CDx assay alongside EMD Serono's Tepmetko.