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 ...
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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 ...
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 ...
ALS News Today12h
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 ...
Cortex, WashU incentives get pushed through St. Louis panel
"This is a very accelerated timeline," said one alderman. "Moving legislation so fast like this, we just want to make sure we're doing the right thing." ...
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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 ...
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 ...
Taiwan News1d
Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring
Cellectar remains confident in the potential of its phospholipid ether drug conjugate platform and the targeted radiotherapies in its development pipeline. Iopofosine I 131’s clinical success ...
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 ...
Cardiff Oncology: Beats Standard Of Care In First-Line Metastatic Colorectal Cancer
Cardiff Oncology's promising Phase 2 trial data for Onvansertib in colorectal cancer may lead to accelerated FDA approval, ...
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uniQure’s (QURE) Stock Soars on FDA’s Accelerated Approval Pathway: A Game-Changer in Gene Therapy
Qure has reached an agreement with the U.S. Food and Drug Administration (FDA) on key elements of an Accelerated Approval pathway for AMT-130, its gene therapy treatment aimed at Huntington’s disease.
UniQure Shares Double After FDA Agreement on Pathway for Huntington's Disease Treatment
UniQure shares more than doubled after the company reached agreement with the Food and Drug Administration on key elements of an accelerated approval pathway for AMT-130, a potential treatment for ...