FDA Backtracks on Huntington’s Disease Gene Therapy

RegMedNet·Nov 3

This story is reported by RegMedNet. Read what other outlets are saying below, then open the original report for full details.

Full coverage

1

uniQure's ballyhooed gene therapy for Huntington's hits FDA roadblock

Fierce Biotech·Nov 3

2

UniQure shares plummet as FDA says inadequate clinical data for Huntington's therapy

Reuters·Nov 3

3

Opinion | The FDA shifts the goalposts on rare disease drugs

The Washington Post·Feb 28

4

REGENXBIO bets on FDA flexibility with filing plans for Duchenne gene therapy

BioSpace·Jun 24

5

US FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval bid

Yahoo Finance·Jun 22

6

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

BioPharma Dive·Mar 31

7

In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy

Fierce Biotech·Jun 22

8

FDA, after turbulent year, leaves drugmakers guessing on its direction

BioPharma Dive·Apr 1