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 ...
STAT1d
Uniqure gets FDA OK to seek accelerated approval
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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 ...
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 ...
Yahoo Finance5d
FDA shares new draft guidance for accelerated approval
The US Food and Drug Administration (FDA) has published new draft guidance for its Accelerated Approval Program, which provides a process for expediting new drugs that serve unmet medical needs ...
Yahoo Finance6d
Merus’ Bizengri granted FDA accelerated approval to treat NRG1+ cancers
Merus’ Bizengri (zenocutuzumab-zbco) has received accelerated approval from the US Food and Drug Administration (FDA), ...
GlobalData on MSN2d
FDA shares new draft guidance for accelerated approval
The new FDA guidance outlines how surrogate or intermediate clinical endpoints can support accelerated approval.
Monthly Prescribing Reference5d
Bizengri Gets Accelerated Approval for NRG1+ NSCLC and Pancreatic Cancer
Patients should be selected for treatment based on the presence of an NRG1 gene fusion in tumor specimens.
pharmaphorum16h
uniQure rockets on map to market for Huntington's therapy
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
ALS News Today11h
FDA outlines steps to consider accelerated approval of CNM-Au8
The U.S. Food and Drug Administration (FDA) signaled that it may be willing to consider granting accelerated approval to ...
Medscape2d
New Cancer Drugs: Do Patients Prefer Faster Access or Clinical Benefit?
Although patients with cancer value speedy access to new drugs, they are often willing to wait for strong evidence ...
uniQure's AMT-130: A Bold Step For Huntington's, But Not Without Hurdles
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...