FDA Approvals

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Benlysta Approved for Children With Lupus

MONDAY, April 29, 2019 -- The intravenous drug Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat children with lupus, a chronic disease that triggers inflammation and damages tissues and organs throughout the body.

Approved for adults since 2011, Benlysta is the first lupus treatment in the United States approved for children, the agency said in a news release.

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Device Helps Doctors Select Lungs for Transplant

MONDAY, April 29, 2019 -- The Xvivo Perfusion System has been approved by the U.S. Food and Drug Administration to help doctors determine whether lungs are suitable for transplant, the agency said in a news release.

The device can temporarily ventilate, oxygenate and pump preservation solution through the lungs, allowing a transplant team to conduct a more thorough assessment of lung function.

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Balversa Approved for Advanced Bladder Cancer

MONDAY, April 15, 2019 -- Balversa (rdafitinib) has been approved by the U.S. Food and Drug Administration to treat adults with advanced or spreading bladder cancer caused by a genetic defect called FGFR3 or FGFR2, the agency said in a news release.

"We're in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient's specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today's approval represents the first personalized treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

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