A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize the availability of s...
Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health technologies in cli...
FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing practices for active pha...
Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs could help prevent or ...
FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alternative funding programs.
Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission meeting with FDA.
FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk of severe liver injur...
Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should correct, but it shoul...
