Top five pharma looks to LifeSphere IDMP for regulatory readiness

ArisGlobal's industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness

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.

Novo Nordisk threatens legal action over Hims & Hers ‘knockoff’ semaglutide pill

The pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers

Apotex scores exclusive Canadian rights to testosterone therapy Nebido

Under the agreement, Apotex’s branded division, Searchlight Pharma, will seek regulatory approval and handle marketing and distribution in Canada

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke

Aicuris’ Pritelivir delivers Phase 3 win in hard-to-treat herpes patients

The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing

Fitch upgrades Biocon Biologics outlook to positive, affirms ‘BB-’ rating

Aarti Drugs reports strong Q3 FY26 performance, PAT surges 58% YoY

On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY