Alva Review-Courier -

In surprise decision, US approves muscular dystrophy drug

 

December 13, 2019



WASHINGTON (AP) — U.S. health regulators approved a second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months ago.

The ruling marks the second time the Food and Drug Administration has granted preliminary approval for the disease based on early results and is likely to stoke questions about its standards for clearing largely unproven medications.

The FDA said late Thursday it approved Sarepta Therapeutics' Vyondys 53 for patients with a form of Duchenne's muscular dystrophy. Duchenne's affects abou...



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