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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...[ Price : $8.95]
FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.[ Price : $8.95]
AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.[ Price : $8.95]
A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to s...