Researchers will use a lipidomic biomarker test to select patients with a poor prognosis who may benefit from an investigational combination therapy.

The regulator approved the indication based on data showing Kisqali with an aromatase inhibitor improved invasive disease-free survival versus just an aromatase inhibitor.

The FDA has offered positive feedback on possible paths forward for accelerated or traditional approval of FLT201 using data from a single-arm study.

The committee recommended the new formulation in two EGFR-mutated advanced NSCLC settings, for which intravenous Rybrevant is already available.

The firm will begin testing a second dose cohort with AMT-191 after receiving a positive recommendation from a data monitoring committee.

The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.

During 2024, the radiopharmaceutical Pluvicto achieved blockbuster status, while sales of the breast cancer drug Kisqali grew 46 percent compared to 2023.

The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.

The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.

While the company is prioritizing RJVA-001 and a lead program in obesity, it's pausing some R&D efforts and laying off 17 percent of its workforce.

The gene-editing treatment will be available to certain patients with sickle cell disease in England as Vertex commits to collecting additional data.