Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose

Novavax and Serum Institute submits Emergency Use Authorisation of vaccine to regulatory agencies in India, Indonesia and the Philippines

Filing for WHO Emergency Use Authorisation this month

Need for integration of various regulatory agencies : Pharma secretary

Integration of various regulatory agencies with a single-window system and putting in place a transparent, stable, predictable and easy to navigate interface.

Thermo Fisher Scientific appoints Anoopa Menon as Director

In her previous roles, Menon led significant digital transformation efforts, implementing predictive analytics, automation

Biocon Biologics signs settlement and lcense agreement to commercialize biosimilar Aflibercept

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

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%

EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization