Gene therapy developer's stock doubles after FDA grants accelerated approval
The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...
BioSpace3dOpinion
Opinion: What Accelerated Approval’s Naysayers Miss
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save ...
BioPharma Dive1d
UniQure shares soar on chance of speedy approval for Huntington’s therapy
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
BioSpace1d
UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...
theregreview5d
Ethical Considerations for FDA Accelerated Approval
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval of a treatment for adults with metastatic ...
DBV Shares Rise 31%, Confirms Alignment With FDA on Accelerated Approval for Peanut Patch
Shares of DBV Technologies were trading higher on the Nasdaq after hours Wednesday, following the company confirming alignment with the Food and Drug Administration on an accelerated approval for its ...
STAT1d
Uniqure gets FDA OK to seek accelerated approval
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FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS
FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS ...
FDA Agrees On Accelerated Approval Pathway For AMT-130 In Huntington's Disease; Stock Up 89%
Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug ...
PharmTech5d
FDA Releases Guidance on Accelerated Approvals
The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.
FierceBiotech22h
Cellectar lays off 60% of staff, ditches lead radiotherapy over FDA demand for another trial
Cellectar Biosciences is laying off 60% of its employees and halting work on its sole clinical-stage radiotherapy after the ...
manilatimes1d
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 ...