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FDA clears a RadiaDyne 510(k) for two new indications for its OARtrac radiation dose monitoring platform.[ Price : $8.95]
FDA commissioner Scott Gottlieb outlines the agencys efforts as part of HHS to address the nations opioid crisis.[ Price : $8.95]
FDA sends PTC Therapeutics a complete response letter for its NDA for ataluren for treating nonsense mutation dystrophinopathies.[ Price : $8.95]
FDA issues Antares Pharma a complete response letter on its NDA for Xyosted (testosterone enanthate) injection for testosterone re...[ Price : $8.95]
Federal Register notice: FDA determines that HRA Pharmas Ovrette (norgestrel) tablets, 0.075 mg, was not withdrawn from sale for r...[ Price : $8.95]
OriGen Biomedical recalls two lots of its Reinforced Dual Lumen catheter due to a separation risk involving the clear extension tu...[ Price : $8.95]
Federal Register notice: FDA classifies zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls)...[ Price : $8.95]
FDA warns Indias Vital Laboratories Pvt. about CGMP violations at its API facility in Gujarat.