Food and Drug Administration News

Health Tips

• Health Tip: Use Medical Devices Safely
  
• Health Tip: Protect Your Food From Hurricane Threats
  
• Health Tip: Pay Attention to Nutritional Information
  

FDA Approvals

• Rozlytrek Approved to Treat Tumors With NTRK Gene Fusion
  Drug also approved to treat metastatic non-small cell lung cancer with ROS1-positive tumors
• Implant Approved to Improve Symptoms in Advanced Heart Failure
  Barostim Neo System indicated for patients not suited for cardiac resynchronization therapy
• New Antibiotic Approved for Community-Acquired Bacterial Pneumonia
  Clinical data show similar results between Xenleta and moxifloxacin with or without linezolid
• Transcatheter Heart Valves Approved for Use in Low-Risk Patients
  Approval expanded to patients with severe aortic valve stenosis at low risk for death, major complications
• FDA Approves Tether Device to Correct Idiopathic Scoliosis
  Device provides alternative to fusion surgery when idiopathic scoliosis not responsive to bracing
• FDA Approves Inrebic Capsules for Myelofibrosis
  Drug approved to treat adults with intermediate-2 or high-risk primary or secondary myelofibrosis