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.
FDA approves Amgens Blincyto (blinatumomab) for treating adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precu...
Federal Register notice: FDA determines that Exela Pharma Sciences diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not withdrawn from sale...
Federal Register notice: FDA announces the withdrawal of two Mammography Quality Standards Act (MQSA) alternative standards due to updated MQSA regula...
FDA grants BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory chronic lymphocytic leukemia or sm...
