In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signaling heightened scrut...
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.
Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered bad cholesterol compared with commonly used non...
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 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.
The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.
