While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be ...

A senior FDC official said the product is a “failed therapy” and confirmed that regulators have asked uniQure to run a new trial to prove the therapy actually helps Huntington’s patients. The ...

UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.

For the first time, scientists have successfully treated someone suffering from Huntington's disease, a fatal genetic illness ...

Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for ...

Add Yahoo as a preferred source to see more of our stories on Google. An exceptionally rare and fatal genetic disease may finally have a solution. Huntington’s Disease affects one in ten to twenty ...

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

Add Yahoo as a preferred source to see more of our stories on Google. MRI of a brain with Huntington's Disease. (Zephyr/Science Source) Every week neurologist Victor Sung sees people with Huntington’s ...

NEW YORK, March 4 (Reuters) - UniQure's trial design for its gene therapy for Huntington's disease did not offer sufficient proof that the drug slowed disease progression, a top U.S. Food and Drug ...

Will Forte, who played MacGruber on Saturday Night Live, and his brother-in-law Doug Modling, who has Huntington's Disease, ...

Amid rising debate within the medical community, the US FDA has spoken out to defend how it reviews and authorizes new ...

AUSTIN (KXAN) — An exceptionally rare and fatal genetic disease may finally have a solution. Huntington’s Disease affects one in ten to twenty thousand Americans. The disease is a mixture of dementia ...