uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License Application (BLA) for Accelerated Approval ~ ~ FDA agrees that the composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval ~ ~ Conference call today at 8:30 a.
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
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UniQure Stock Doubles After Striking A Deal With The FDA For Huntington's DrugUniQure stock doubled Tuesday after the company reached a testing agreement with the FDA for its Huntington's disease ...
Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug ...
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Heart medication may slow the progression of Huntington's diseaseResearch indicates β-blockers may reduce the risk of motor diagnosis and slow symptom progression in Huntington's disease, ...
UniQure (NASDAQ:QURE) stock shot up 90% Tuesday morning on news that the company had reached an agreement with the FDA on key ...
A patient in the UK has received a new therapy for Huntington’s disease, which experts hope could slow progression of the fatal illness. Huntington’s is an inherited condition that is caused ...
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