Pharma overhaul: EMA hails “Once-in-a-Generation” reform
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
The drug is currently being evaluated in two fully recruited global Phase 3 studies for progressive and tophaceous gout, with results expected in 2026.
In her previous roles, Menon led significant digital transformation efforts, implementing predictive analytics, automation
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
Subscribe To Our Newsletter & Stay Updated