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 issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigational cell therapy for...
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 cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting sto...
FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.
AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.
