The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
The initiative, delivered in collaboration with Accenture, integrates digitally enabled operating models powered by advanced analytics and AI across the company’s procurement, manufacturing, and distribution networks
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
mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe
DeslaFlex is an innovative antidepressant formulation developed by Spektus using the proprietary Flexitab oral drug-delivery platform
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
Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units
Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN
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