8 recent drug, device approvals

Eight drugs and medical devices approved by the FDA since May 4:

  1. FDA approves drug to treat rare nervous system disease
    The FDA approved Viela Bio's Uplizna, designed to treat neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.

  2. FDA approves antibiotic to treat hospital-acquired bacterial infection
    The FDA approved Merck's Recarbrio, an antibiotic designed to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults.

  3. FDA approves sedative for ventilator use
    The FDA approved Gland Pharma's dexmedetomidine hydrochloride, a sedative designed to help intubate patients to be placed on a mechanical ventilator.

  4. FDA approves first US drug to treat severe malaria
    The FDA approved Amivas' artesunate for injection, designed to treat severe malaria in adults and children.

  5. FDA approves first drug for pediatric bladder disorder
    The FDA approved Astellas Pharma's VESIcare, designed to treat a form of bladder dysfunction related to neurological impairment in children ages 2 years and older.

  6. FDA approves muscle relaxant drug for ventilator use
    The FDA approved Nivagen Pharmaceuticals' succinylcholine chloride injection, designed to provide skeletal muscle relaxation during surgery or ventilation.

  7. FDA approves Philips defibrillator device
    The FDA approved Philips Medical Systems' HeartStart FRx Defibrillator, a battery-powered automated external defibrillator designed to treat sudden cardiac arrest.

  8. FDA approves abdominal stent-graft device
    The FDA approved Bolton Medical's Treo Abdominal Stent-Graft System, designed to repair an aneurysm of the abdominal aorta. 

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