Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.
FDA warns Durham, NC-based CARsgen Therapeutics about CGMP violations in its production of investigational drugs and biologics used in a Phase 2 trial...
Federal Register notice: FDA announces the issuance of an emergency use authorization for Octapharmas freeze-dried plasma product, octaplasLG Powder, ...
FDA warns Watertown, MA-based EyePoint Pharmaceuticals about CGMP violations in its production of finished drugs.
FDA approves an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indications.
FDA explains its rationale for making six changes to the emergency use authorization for Invivyds Pemgarda Covid-19 pre-exposure prophylaxis agent.
FDA chief medical officer Hilary Marston explains in a podcast how the agency is expanding its use of real-world data and evidence.
FDA grants Ractigen Therapeutics an orphan drug designation for RAG-18 and its use in treating Duchenne Muscular Dystrophy.
