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.
FDA approves Amgens Blincyto (blinatumomab) for treating adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precu...
A group of researchers find that about half of the over 500 AI devices allowed to enter the market since 2016 lack reported clinical validation data.
FDA turns up the pressure on iRhythm Technologies based on a second Form FDA-483 issued last month at the companys Cypress, CA manufacturing facility ...
