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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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 ...
Hosted on MSN7h
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 ...
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 ...
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Biotech Stock Roundup: BIOA Down on Study Update, QURE, CRDF Gain on Study Data & More
It was a busy week in the biotech sector with lots of data readouts. This apart, the key regulatory updates and pipeline news ...
theregreview4d
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 ...
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 ...
Medscape9d
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) for ...
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 ...
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, ...