The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.
1 report, 1 independent
Updated Aug 6
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What happened
The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- FDA placed a clinical hold on RGX-121 trials, leading to a sharp decline in REGENXBIO Inc.'s stock price.Sub-event
FDA provided milestone payments and reviewed gene therapy applications for Regenxbio and AbbVie.1 source
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The entities involved
Related events
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- The FDA approved various advanced therapies, including oral medication from Roche, a gene-targeting drug from Biogen, and a one-time gene therapy from Novartis.
- uniQure N.V. traded on the Nasdaq stock exchange and submitted a Biologics License Application (BLA) for accelerated approval of its gene therapy.