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Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection
The agency took another step toward clearing a backlog of Makary-era rejections that appeared to contradict earlier agreements with drugmakers.
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biopharmadive.com
Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection
The agency took another step toward clearing a backlog of Makary-era rejections that appeared to contradict earlier agreements with drugmakers.
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statnews.com
FDA reverses course on Regenxbio’s childhood gene therapy after rejection
The FDA will reconsider approving Regenxbio's experimental gene therapy for a deadly and rare childhood brain disorder it rejected just four months ago.
