The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The decision is based on the phase 3 DESTINY-Breast11 trial
The facility will bring 850 high-value jobs to the region, including engineers, scientists, operations personnel, and lab technicians
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
GS-098, a first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor, is designed to rapidly block the pathogenic activity of thyroid-stimulating autoantibodies
The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
Data show adjuvant Verzenio plus endocrine therapy extends overall survival and sustains long-term improvements in invasive disease-free survival
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