FDA to launch pilot program to speed up early-stage clinical trials

FDA selects Eli Lilly, Regeneron, and five others for PreCheck pilot to speed manufacturing facility reviews

The FDA has selected Eli Lilly, Regeneron, and five other pharmaceutical companies for its PreCheck pilot program, which allows regulators t

China creates new regulatory pathway to accelerate access to advanced biomedical therapies

China has established a new regulatory "tech track" for advanced therapies like personalized cancer treatments, cell and gene therapies, and

Proposed CDC science office could tighten political control at agency

China's biotech rise: A case study in multiple myeloma drug development

This article examines China's rapid advancement in biotechnology through the lens of a multiple myeloma drug development case study. It disc

FDA's AI for Drug Approvals Found to Fabricate Studies

The FDA's AI system, designed to expedite drug approvals, has been discovered to generate fake studies and misrepresent research, raising co

U.S. restrictions on Chinese biotechnology could harm patients, argues editorial

The article argues against U.S. efforts to restrict collaboration with China's biotechnology industry, framing it as an extension of the tec