FDA Alleges Uniqure Misrepresented Request In Rare-Disease Drug Approval

FDA Alleges Uniqure Misrepresented Request In Rare-Disease Drug Approval FDA and HHS officials have publicly attacked Uniqure, the biotech company seeking approval for a Huntington’s disease treatment, and accused it of lying about requests made by the FDA for additional studies involving placebo brain surgery, which the company has characterized as unethical. The company says the anonymous FDA statements "are incomplete or entirely incorrect.” https://kffhealthnews.org/morning-breakout/fda-alleges-uniqure-misrepresented-request-in-rare-disease-drug-approval/