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Federal Register notice: FDA determines the patent extension-related regulatory review period for Janssen Biotechs Tremfya (guselk...[ Price : $8.95]
Federal Register notice: FDA debars Isachi Gil for six years from providing services in any capacity to a person that has an appro...[ Price : $8.95]
FDA solicits comments on two proposed CDER Office of Prescription Drug Promotion research projects.[ Price : $8.95]
FDA chief of staff Lauren Silvis says the agency is evolving to keep pace with technology advances, and one area it wants to focus...[ Price : $8.95]
FDA clears a CoreLink Surgical 510(k) for the 3-D printed M3 Stand-Alone Anterior Lumbar System.[ Price : $8.95]
FDA accepts for priority review an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in ...[ Price : $8.95]
Five stakeholders respond to an FDA draft guidance on use of expansion cohorts in some oncology trials.[ Price : $8.95]
FDA and the Department of Homeland Security sign a Memorandum of Understanding on medical device cybersecurity coordination.