The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

The API is, one might say, the most important element in a pharmaceutical product. Poor-quality APIs that do not meet potency ...

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

IASO Biotherapeutics ('IASO Bio'), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced ...

Iambic, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, published on major advances to Enchant, Iambic’s ...

Artificial Intelligence (AI) continues to transform various scientific fields through extraordinary innovations and cutting-edge discoveries. The integration of AI in ...

Officials from the Indianapolis-based drugmaker said the Lilly Medicine Foundry will help streamline the process of ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half ... “We need to build factories … because our research and ...