HEALTHSTAT NEWS
STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval
The FDA has reversed its opposition to UniQure's experimental Huntington’s disease treatment AMT-130, allowing the company to file for U.S. approval. UniQure plans to submit a marketing application in Q3 for accelerated approval, citing a three-year analysis of early-stage study data as acceptable to the FDA, despite previous objections from former agency officials.
Mentioned
Related Signal
Adjacent reporting
- STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more
- STAT+: FDA to reconsider treatment for rare cancer after its surprise rejection
- FDA Blocked Melanoma Drug as Confusion Reigned Under Makary
- New option available for Alzheimer’s patients as FDA approves expanded drug use
- STAT+: FDA approves Sanofi diabetes drug for children with stage 3 diabetes
- STAT+: Pharmalittle: We’re reading about an AstraZeneca breast cancer pill, an ADAP deal in Florida, and more