Category: biologic medicines

  • FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

    China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. […]