Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU.

RADIANT study with vormatrigine in focal onset seizure (FOS) patients over eight weeks demonstrated 56.3% median reduction in ...

Eli Lilly and Novo Nordisk are actively exploring other medical uses for their GLP-1 drugs, and have already seen some success ...

Risk assessment for potential mutagenic side-products is still required by regulatory bodies, despite lack of evidence they ...

Data from the DELIVER registrational expansion cohort is expected in late 2025, with a potential BLA submission for U.S. accelerated approval anticipated in early 2026 - ...

Biogen’s Qalsody (tofersen) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as the first ...

With one year until new rules on ‘high-risk’ AI systems take effect in the EU, pharmaceutical companies using AI in the process of drug development need clarity on whether the rules will apply to them ...