A senior FDC official said the product is a “failed therapy” and confirmed that regulators have asked uniQure to run a new ...
Subjecting participants to invasive procedures without the prospect of therapeutic benefit is unjustifiable,” says the CEO of ...
By Michael Erman and Puyaan Singh March 5 (Reuters) - A senior FDA official called UniQure's experimental treatment for ...
UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.
In a strikingly blunt briefing, a senior FDA official accused uniQure of pushing “distorted” data to mask a “failed” therapy ...
Gene Therapy Meets Regulatory Reality: The FDA–uniQure Clash Over a Promising Huntington’s Treatment
The FDA’s dispute with biotech firm uniQure over Huntington’s gene therapy highlights growing tensions between innovation, ...
CLEVELAND, Ohio — Whole brain radiotherapy saves lives by treating cancer that has spread to the brain, but it also causes long-standing brain damage. Many patients who go through whole brain ...
By Puyaan Singh and Christy Santhosh March 2 (Reuters) - UniQure said the U.S. drug regulator called for a new study to ...
Gene therapy that can cross the blood–brain barrier represents a non-invasive way to map gene expression in the brains of ...
Researchers demonstrated that released markers of activity (RMAs), engineered proteins that cross the blood-brain barrier and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results