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FDA says GlaxoSmithKlines sotrovimab is now not authorized for use in any HHS region because the proportion of Covid-19 cases from...[ Price : $8.95]
CDER director Patrizia Cavazzoni outlines budget priorities for FY 2023, including a priority to improve drug postmarket surveilla...[ Price : $8.95]
FDA approves a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesi...[ Price : $8.95]
FDA warns Monterey, CA-based NDAL Mfg. that it is manufacturing unapproved new drugs with CGMP violations.[ Price : $8.95]
AstraZeneca and Janssen comment on an FDA draft guidance on immunogenicity information in drug product labeling.[ Price : $8.95]
FDA says the availability of duodenoscopes that are fully disposable or have disposable components should lead to hospitals and en...[ Price : $8.95]
Seven senators ask the HHS Inspector General to look into McKinsey & Company's conflicts of interest while working with FDA and th...[ Price : $8.95]
Immunome plans a Phase 1b trial after FDA lifts a clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19.