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.
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
Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units
The enhancements will improve environmental sustainability, strengthen material governance, and boost utility reliability
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
Alto met its enrollment goal with 83 patients across 13 US clinical sites
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
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