FDA, Accelerated Approval
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 biliary tract cancer —a condition with less than a 5 percent five-year survival. Doctors explained that this approval addresses the unmet need for effective treatment for patients with this disease.
The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...
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 ...
Qure N.V. QURE surged 109.7% after it announced reaching alignment with the FDA on key elements of an accelerated approval ...
FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS ...
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...
A new review published in Blood Cancer Discovery outlines a major multiple myeloma research project that supported a key ...
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
In October, the US Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix, Novartis AG) ...
Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug ...
Cellectar Biosciences is laying off 60% of its employees and halting work on its sole clinical-stage radiotherapy after the ...
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