FDA attack on UniQure sparks new political headache over rare-disease drugs
TL;DR Summary
An FDA-organized media call featured a senior FDA official publicly attacking UniQure’s Huntington’s disease gene therapy, calling its data distorted and the therapy failed, a move seen as injecting politics into rare-disease regulation and potentially complicating oversight ahead of elections, with echoes of recent vaccine-review controversies and congressional pressure on the agency.
- The FDA, urged to avoid controversy, creates a new headache with attack against UniQure statnews.com
- FDA goes on offense amid surge of criticism for recent drug decisions CNN
- Federal Health Officials Attack Rare-Disease Drug, Say Company Lied WSJ
- FDA official calls UniQure's gene therapy a 'failed' treatment for Huntington's disease CNBC
- Pressure builds as back-and-forth between uniQure and FDA intensifies Fierce Biotech
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