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FDA officials list ways in which the agency is promoting the development of pediatric medicines.[ Price : $8.95]
FDA raises efficacy questions about a Y-mAbs BLA for I-omburtamab to treat pediatric patients with CNS/leptomeningeal metastases f...[ Price : $8.95]
The CDRH Digital Health Center of Excellence releases a document highlighting topics of interest for regulatory science research a...[ Price : $8.95]
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.