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Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular a...[ Price : $8.95]
Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or ...[ Price : $8.95]
FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulati...[ Price : $8.95]
FDA sends Astellas Pharma a complete response letter on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) ...[ Price : $8.95]
Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregiona...[ Price : $8.95]
Merck reports positive topline results from a trial that evaluated the noninferiority of subcutaneous administration of Keytruda (...[ Price : $8.95]
FDA seeks input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZenecas Andexxa and an increased...[ Price : $8.95]
GSK says its Phase 3 GLISTEN trial evaluating linerixibat in adults with a relentless itch associated with primary biliary cholang...