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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.

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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.

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lunedì 22 giugno 2026·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.
lunedì 22 giugno 2026·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.

FDA reverses course on Regenxbio’s childhood gene therapy after rejection

Confronto fonti

FDA reverses course on Regenxbio’s childhood gene therapy after rejection

Timeline cronologica

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

FDA reverses course on Regenxbio’s childhood gene therapy after rejection

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