FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemoly...
FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the therapy lacks reliable...
FDA seeks to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a broader pilot program...
A Quality Magazine article explains what FDA investigators have focused on in their initial Quality Management System Regulation inspections.
FDA releases the form FDA-483 issued after a 2024 inspection at the Excelvision drug manufacturing facility in Annonay, Ardche, France.
FDA grants a fast track designation to Scancells advanced melanoma investigational drug iSCB1+.
FDA commissioner Marty Makary says the agency is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the a...
Rocket Pharmaceuticals sells an FDA rare pediatric disease priority review voucher for $180 million to support its gene therapy pipeline.
