uniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for ...

FDA accepts uniQure's one-time Huntington's gene therapy for review—but approval is still uncertain

The FDA accepted uniQure's AMT-130 application for Huntington's disease, granted priority review, and set a May 1, 2027, target decision date while approval remains uncertain.

UniQure gets an FDA decision date; Teva scraps brain drug study

The FDA appears likely to hold an advisory committee for UniQure’s closely watched Huntington’s disease gene therapy. Elsewhere, a biotech’s share price was cut in half following a regulatory setback.

uniQure set for May FDA verdict on Huntington's gene therapy

The FDA has started its review of uniQure's gene therapy for neurodegenerative disorder Huntington's, but will require an advisory committee meeting.

FDA to review uniQure's Huntington's gene therapy, decision due on May ...

uniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for ...

~ FDA sets PDUFA target action date of May 1, 2027 ~

uniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for ifezuntirgene inilparvovec for the Treatment of Huntington’s Disease

~ FDA sets PDUFA target action date of May 1, 2027 ~ ~ If approved, ifezuntirgene inilparvovec will be the world’s first disease-modifying treatment for...