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 ...

Investing.com -- Dyne Therapeutics Inc (NASDAQ: DYN) stock rose 3.6% after the company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its ...

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 ...