FDA warns Grand Prairie, TX-based Analytical Food Laboratories about CGMP violations in its work as a drug contract testing laboratory.
FDA clears a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons through artificial intelligence-based image processing.
FDA extends by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with certain types of lung and pancreati...
Four rare disease stakeholders say they support an FDA plan to create a Rare Disease Innovation Hub and suggest its initial priorities.
Attorney Bradley Thompson says he is surprised and disappointed that FDA is not approving enough new consensus standards to support digital health and...
Mark Cubans Cost-Plus Manufacturing and Compounding facility in Dallas, TX, receives a Form FDA-483 based on findings from a recent inspection.
FDA accepts for review an Ionis Pharmaceuticals NDA for donidalorsen, an RNA-targeted treatment for preventing hereditary angioedema attacks.
FDA gives the green light to Phaxiam Therapeutics for a Phase 2 study (GLORIA) to evaluate its anti-Staphylococcus aureus phages in prosthetic joint i...
