The agency last December approved subcutaneous Rybrevant on a biweekly dosing schedule across all of its indications.
Researchers evaluated a different chemo regimen in combination with Braftovi and Erbitux, which is already approved with mFOLFOX6.
Distance, lack of coverage, and mistrust have limited Indigenous patients' access to basic and advanced medicine, but cancer centers are embracing strategies to change that.
The firm originally submitted a new drug application seeking approval of the drug in 2016, which was rejected, and, in 2024, resubmitted an application.
The company acquired GH31 from Chinese firm Genhouse for $80 million up front and will test it in tumors with MTAP deletions.
The company is expecting additional readouts this year from studies of cancer vaccine intismeran autogene, which is being tested in late-stage trials.
Researchers are evaluating Lyell's CD19/20 dual-targeting CAR-T against marketed CD19 CAR T-cell therapies in the second-line refractory large B-cell lymphoma setting.
Ultragenyx recently resubmitted a BLA seeking approval for the gene therapy after the FDA rejected it, and the firm will resubmit it again in response to new questions.
Vertex posted revenue and earnings for Q4 and full-year 2025 that hovered around consensus Wall Street estimates, but CRISPR Therapeutics missed expectations.
The company is also developing an assay to identify best responders to the therapy, which may include patients with certain lung, pancreatic, and kidney tumors.
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