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 ...
BioSpace5d
FDA Outlines Accelerated Review Guidelines in Waning Days of Biden Administration
The program has recently become controversial as a number of high-profile advanced approvals were granted only for the drugs ...
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 ...
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 ...
Zacks.com on MSN9h
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 ...
BioSpace2dOpinion
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 ...
PharmTech5d
FDA Releases Guidance on Accelerated Approvals
The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.
Investor's Business Daily on MSN1d
UniQure Stock Doubles After Striking A Deal With The FDA For Huntington's Drug
UniQure stock doubled Tuesday after the company reached a testing agreement with the FDA for its Huntington's disease ...
FierceBiotech15h
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 ...
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 ...
Why Is uniQure Stock Skyrocketing On Tuesday?
Qure stock surges after FDA agrees on an accelerated approval pathway for its Huntington's disease treatment, AMT-130.
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) for ...