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 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 enhancements will improve environmental sustainability, strengthen material governance, and boost utility reliability
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
Duvakitug was well tolerated and safety was consistent with the induction study
Iberdomide has the potential to be the first approved CELMoD agent
Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research
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