STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval

·STAT News··

The Food and Drug Administration has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker, the biotech company UniQure, to file for U.S. approval, the company said Wednesday.  UniQure will submit a marketing application in the third quarter seeking accelerated approval for the treatment, called AMT-130. The decision comes after a recent meeting with FDA officials during which the agency agreed that a three-year analysis of an...

Read full article →

Related Articles

Does Employment Slow Cognitive Decline? Evidence from Labor Market Shocks
littlexsparkee · Hacker News · 1mo ago
Group averages obscure how an individual's brain controls behavior: study
hhs · Hacker News · 1mo ago
Underwater robot tracks sperm whale conversations in real time
thedebuglife · Hacker News · 1mo ago
Researchers print structural colour with an inkjet printer
zeristor · Hacker News · 1mo ago
Urban Birds Are Rising Earlier Because of Traffic Noise (2013)
thunderbong · Hacker News · 1mo ago