News | February 18, 2022
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
ArisGlobal's industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness
Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose
Filing for WHO Emergency Use Authorisation this month
Integration of various regulatory agencies with a single-window system and putting in place a transparent, stable, predictable and easy to navigate interface.
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
On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
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