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...
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...
Scholar Rock resubmits its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy.
A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receives an FDA breakthroug...
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the pharmaceutical indu...
FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality checks.
