The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
DeslaFlex is an innovative antidepressant formulation developed by Spektus using the proprietary Flexitab oral drug-delivery platform
Backed by a multi-hundred-million-dollar investment, the expansion underscores Sanofi’s long-term commitment to India’s thriving life sciences ecosystem
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
Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN
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 designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
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
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