[ Price : $8.95]
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the...[ Price : $8.95]
FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality check...[ Price : $8.95]
In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signal...[ Price : $8.95]
FDA accepts for priority review a Praxis Precision Medicines NDA for relutrigine, an investigational therapy targeting rare geneti...[ Price : $8.95]
FDA approves a higher-dose regimen of Biogens Spinraza (nusinersen) for treating spinal muscular atrophy.[ Price : $8.95]
Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered bad cholesterol compared wi...[ Price : $8.95]
FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children wi...[ Price : $8.95]
FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.