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Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.[ Price : $8.95]
FDA warns Durham, NC-based CARsgen Therapeutics about CGMP violations in its production of investigational drugs and biologics use...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of an emergency use authorization for Octapharmas freeze-dried plasma product,...[ Price : $8.95]
FDA warns Watertown, MA-based EyePoint Pharmaceuticals about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA approves an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indicati...[ Price : $8.95]
FDA explains its rationale for making six changes to the emergency use authorization for Invivyds Pemgarda Covid-19 pre-exposure p...[ Price : $8.95]
FDA chief medical officer Hilary Marston explains in a podcast how the agency is expanding its use of real-world data and evidence...[ Price : $8.95]
FDA grants Ractigen Therapeutics an orphan drug designation for RAG-18 and its use in treating Duchenne Muscular Dystrophy.