News | February 24, 2022
Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine
100% efficacy against severe Covid-19 disease and hospitalizations
100% efficacy against severe Covid-19 disease and hospitalizations
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.
The newly formed SAB will provide strategic direction across research, clinical development, and regulatory pathways
By prioritising absolute compliance, leveraging the power of digital tools, and aligning with government policies, the sector is locking in its future leadership
Shift from approvals to digital intimation via NSWS portal aims to cut timelines and boost innovation in early-stage drug development
PMDA is regarded among the most stringent regulatory bodies globally
The litigation involved multiple civil lawsuits alleging anti-competitive practices and violations of federal
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