Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for ...
The Commissioner’s National Priority Voucher pilot program enabled rolling review, enhanced FDA interaction, and a rapid 44-day decision, alongside breakthrough therapy and priority review ...
CEO Sean Nolan stated, “The recent regulatory clarity and progress we've achieved, which was enabled by the strength of our REVEAL Part A data set, rigorous data evaluation methodology, and our ...
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