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 recommendation, based on data from the SERENA-6 trial, breaks from the opinion of an FDA advisory committee last month.

The regulator approved the toripalimab and disitamab vedotin combo for HER2-expressing urothelial carcinoma patients who had no prior systemic therapy.

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 partners will stop developing BIIB122 in an all-comer population, but Denali will keep evaluating it in those with LRRK2 pathogenic variants.

Foundation Medicine previously received companion diagnostic approval for its FoundationOne Liquid CDx assay alongside EMD Serono's Tepmetko.

Dyne Therapeutics is beginning a Phase III trial of its therapy, zeleciment rostudirsen (z-rostudirsen), for Duchenne muscular dystrophy patients amenable to exon 51 skipping ahead of filing for its ...

Krystal Biotech is the furthest along in pursuing this approach and is ironing out details of a registrational trial for its ...

The EMA accepted Regeneron's marketing authorization application for the gene therapy and will review it under accelerated assessment.

The task force that makes recommendations on cancer screening, including genetic testing, hasn't met since March 2025 but ...

Even though Arvinas and Pfizer appear to have "written off" the drug, in one analyst's view, Rigel believes it can drive adoption among community-treated patients lacking SERD access.