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FDA News Briefs for Monday, April 29, 2019

April 29, 2019

These Food and Drug Administration (FDA) developments came in last week:


FDA Approves Benlysta for Pediatric SLE

The FDA has approved an expanded indication for Benlysta (belimumab; GlaxoSmithKline) for the treatment of children aged 5 years and older with systemic lupus erythematosus (SLE). Benlysta is the first FDA-approved treatment for pediatric patients with SLE; it has been approved for use in adult patients since 2011.  More Information.


FDA Grants PMA for XPS with Steen Solution

The FDA has granted a premarket approval (PMA) for XPS with Steen Solution (XVIVO Perfusion Inc.), a normothermic preservation system for transplantation of initially unacceptable donor lungs. This device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation.  More Information.