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.

These boards are cropping up around the US as neurologists acclimate to a new class of drugs, but not everyone agrees such ...

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

The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.

NEW YORK – Fractyl Health on Friday said it intends to initiate a first-in-human trial of a gene therapy it's developing to treat type 2 diabetes, RJVA-001, in the first half of 2025. Burlington, ...

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

The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.

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

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