FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for their weight loss dr...
A new JAMA analysis finds that FDAs regulation of mifepristone has been driven largely by scientific evidence and internal expert judgment, with limit...
FDA accepts for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cell tumor.
FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigational cell therapy for...
FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the agency says is intende...
FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic cancer.
FDA approves a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.
FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.
