In late July, the U.S. Food and Drug Administration (FDA) made a shocking choice to resume administering Elevidys, even though the drug was put on hold earlier this year. Elevidys is a one-time gene therapy used to treat Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes muscle weakness and loss. The therapy works by creating a version of the dystrophin gene, which is needed to strengthen muscle cells. It was developed by Sarepta Therapeutics and initially approved by … Continue reading The FDA strikes again. Here’s how agile CROs can help.