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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.[ Price : $8.95]
The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.[ Price : $8.95]
Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.[ Price : $8.95]
FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycl...