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FDA Defends Controversial Drug Approval Decisions Amid Rising Criticism

KVIA•Thursday, March 5, 2026 at 10:03 PM•CNN Newsource

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In an unusual move, a senior FDA official defended the agency's recent decision to require additional trials for UniQure's gene therapy for Huntington's disease, labeling it a 'failed therapy.' This decision, which disappointed patients and the company hoping for swift approval, has sparked significant backlash, including accusations of inconsistency in the FDA's approval process. Critics, including former FDA official Dr. Janet Woodcock, have raised concerns about the agency's evolving standards, particularly following a controversial decision regarding Moderna's flu vaccine. The FDA official emphasized the necessity of placebo-controlled trials to validate new treatments, countering claims that the agency's requirements were unreasonable.

Key Details: • UniQure was asked to conduct additional clinical trials for its Huntington's disease therapy. • FDA officials claim that the agency's requirements for trials are consistent with longstanding policies. • Criticism has been directed at the FDA for perceived changes in approval processes for various drugs.

fda clinical-trials biotechnology drug-approval huntingtons-disease

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US Food and Drug AdministrationModernaJanet WoodcockUniQure

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