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 ...
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 ...
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 ...
Hosted on MSN13h
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 ...
Medscape10d
Accelerated Approval of New Frontline TKI Use in CML Raises Questions
The use of accelerated approval will continue to be a balancing act, due in part to demand for newer agents, said Ravi ...
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 ...
Hosted on MSN1d
UniQure Stock Doubles After Striking A Deal With The FDA For Huntington's Drug
UniQure stock nearly doubled Tuesday after the company reached a testing agreement with the FDA for its Huntington's disease ...
Monthly Prescribing Reference5d
Bizengri Gets Accelerated Approval for NRG1+ NSCLC and Pancreatic Cancer
Patients should be selected for treatment based on the presence of an NRG1 gene fusion in tumor specimens.
EurekAlert!2d
Filling out the roadmap for faster drug approvals
A new review published in Blood Cancer Discovery outlines a major multiple myeloma research project that supported a key ...
BioSpace9d
FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...
FierceBiotech19h
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 ...