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Three FDA staffers give an update on the agencys position on paclitaxel-coated devices used to treat peripheral arterial disease.[ Price : $8.95]
FDA issues an immediately effective guidance to help sponsors develop monoclonal antibodies and other therapeutic proteins for tre...[ Price : $8.95]
FDA issues a report summarizing its Pandemic Recovery and Preparedness Plan Initiative work in the second half of 2020.[ Price : $8.95]
FDA releases minutes and meeting summaries for five PDUFA 7 negotiation meetings at the end of 2020.[ Price : $8.95]
Former CDER director Janet Woodcocks recent move to the Office of Commissioner sets in motion her likely elevation to acting commi...[ Price : $8.95]
Federal Register notice: HHS issues a final rule to promote transparency and fairness in civil enforcement actions.[ Price : $8.95]
FDA grants Timber Pharmaceuticals an orphan drug designation for TMB-003, a locally delivered formulation of sitaxsentan, indicate...[ Price : $8.95]
FDA tells Marinus that Marigold study data appear sufficient to justify filing an NDA for oral ganaxolone to treat children and ad...