FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
40+ most innovative startups with disruptive contributions across MedTech, Medical Devices, BioPharma, Cell and Gene Therapy, AI and ML, Nutraceuticals, and Biomarkers exhibited their cutting-edge solutions
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
Each company will share operational data with Evinova, feeding the platform’s AI engines to provide benchmarks and actionable insights, aiming to speed up trials while maintaining top-tier patient care
Wegovy is now offered in six weekly doses in the EU: 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and the newly approved 7.2 mg dose
A final tranche of €12 million will follow, contingent on positive pivotal study results, with the share price calculated according to an agreed formula
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
The NIRSE-GAL study, conducted in Galicia, Spain, is the first real-world, population-based investigation of a universal RSV immunization program spanning two consecutive seasons
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
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