USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
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
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
The enhancements will improve environmental sustainability, strengthen material governance, and boost utility reliability
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
Duvakitug was well tolerated and safety was consistent with the induction study
mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe
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