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CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draf...[ Price : $8.95]
FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the ag...[ Price : $8.95]
FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic ca...[ Price : $8.95]
FDA approves a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in ped...[ Price : $8.95]
FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigatio...[ Price : $8.95]
A new JAMA analysis finds that FDAs regulation of mifepristone has been driven largely by scientific evidence and internal expert ...[ Price : $8.95]
FDA accepts for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cel...[ Price : $8.95]
FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including del...