The 1st pediatric dengue vaccine, a wearable arrhythmia monitor & more: 5 recent FDA approvals

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Five drugs or medical devices have been approved by the FDA since April 26:

1. Dengvaxia is the first approved vaccine for the prevention of dengue disease in children ages 9-16 who live in endemic areas.

2. Mavyret is a tablet that treats all six genotypes of hepatitis C in children ages 12-17. It was previously approved for use in adult patients in 2017.

3. Xvivo Perfusion System can temporarily ventilate, oxygenate and pump preservation solution through lungs intended for transplant. The system aims to help transplant teams better determine whether the lungs are viable for transplant.

4. Benlysta, an intravenous infusion, is the first treatment for pediatric patients with lupus.

5. RX-1 is a wearable device that continuously monitors a patient’s ECG to detect cardiac arrhythmias. That information is then automatically relayed to physicians via the cloud.

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