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 ...
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 ...
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 ...
Hosted on MSN15h
QURE Soars on FDA Alignment for Speedy Approval of Huntington's Drug
Qure N.V. QURE surged 109.7% after it announced reaching alignment with the FDA on key elements of an accelerated approval ...
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 ...
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 ...
New path toward faster drug approvals for multiple myeloma treatment
A new review published in Blood Cancer Discovery outlines a major multiple myeloma research project that supported a key ...
Medscape10d
Accelerated Approval of New Frontline TKI Use in CML Raises Questions
In October, the US Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix, Novartis AG) ...
pharmaphorum22h
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 ...
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 ...
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 ...