Tag: Food & Drug Administration
Remede System Approved for Central Sleep Apnea
Implantable device approved to treat moderate to severe central sleep apnea
First Test to Detect Zika in Blood Donations Approved
Not designed to diagnose the infection, however
FDA: New Glucose Monitoring System Eliminates Finger Pricks
Instead, sensor is implanted below skin in patients with diabetes
FDA Approves Aliqopa for Follicular Lymphoma
Aliqopa, a kinase inhibitor, blocks several enzymes that promote cell growth
FDA Permits Marketing of App to Help Treat Substance Abuse
But app is not recommended for opioid dependence
FDA Approves First Biosimilar Drug for Cancer
Mvasi (bevacizumab-awwb) is biosimilar to Avastin
FDA Approves Pediatric Treatment for Chagas Disease
Benznidazole sanctioned for children aged 2 to 12
FDA Approves First Gene Therapy in the United States
Kymriah approved for patients up to 25 years of age with refractory or relapsed B-cell precursor ALL
FDA Approves Vabomere for Complicated UTIs
IV antibiotic sanctioned for certain complicated urinary tract infections, including pyelonephritis
FDA Cites ‘Significant Deviations’ at Florida Stem Cell Clinic
Agency concerned about 'significant deviations from current good manufacturing practice requirements'
