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A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...[ Price : $8.95]
Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy faile...[ Price : $8.95]
FDA approves Daiichi Sankyos Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative bre...[ Price : $8.95]
FDA has approved Gilead Sciences Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking ...[ Price : $8.95]
Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.[ Price : $8.95]
React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and p...[ Price : $8.95]
FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.[ Price : $8.95]
FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonize...