Eli Lilly wins FDA approval for Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are overweight with related ...
Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should correct, but it shoul...
FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing practices for active pha...
A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize the availability of s...
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...
