Pregabalin was associated with an increased risk for heart failure relative to another widely used gabapentinoid, based on an ...

Kisunla’s active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a ...

The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.

CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...

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 ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has ...

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 ...

Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) is one of the Stocks With Huge Catalysts on the Horizon. On July 25, Ionis ...

KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) is one of the Stocks With Huge Catalysts on the Horizon. On July 25, KalVista ...

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 - ...