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GSK decides not to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled 510(k) Third-Party Review Program.[ Price : $8.95]
An FDA advisory committee votes to recommend approval of GlaxoSmithKlines anemia drug daprodustat for use in treating chronic kidn...[ Price : $8.95]
Attorney Michelle Yeary says a California state court granted Medtronic summary judgment on several product liability claims invol...[ Price : $8.95]
FDA announces the retirement of CDER Office of Compliance director Don Ashley.[ Price : $8.95]
FDA principal deputy commissioner Janet Woodcock says the agency is exploring what flexibility it has in reviewing the science and...[ Price : $8.95]
Federal Register notice: FDA announces an Emergency Use Authorization for Abbott Molecular and its Alinity m MPXV monkeypox diagno...[ Price : $8.95]
FDA makes available a draft guidance entitled Clostridioides difficile Infection (CDI): Developing Drugs for Treatment, Reduction ...