Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should correct, but it shoul...
FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing practices for active pha...
A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receives an FDA breakthroug...
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the pharmaceutical indu...
FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality checks.
In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signaling heightened scrut...
FDA accepts for priority review a Praxis Precision Medicines NDA for relutrigine, an investigational therapy targeting rare genetic epilepsies.
FDA approves a higher-dose regimen of Biogens Spinraza (nusinersen) for treating spinal muscular atrophy.
