Uniqure CEO Matt Kapusta shared critical insights with investors at a private dinner, emphasizing the Trump administration’s discontent with the ongoing turmoil within the Food and Drug Administration (FDA). This statement comes on the heels of Uniqure’s announcement that the FDA has disrupted its expedited approval plans for a gene therapy targeting Huntington’s disease.
Kapusta’s remarks reflect a broader context of regulatory challenges facing the biopharmaceutical industry, particularly as the appointment of Rick Pazdur as the FDA’s top drug regulator signals a renewed focus on stabilizing the agency’s operations. Pazdur’s initial reluctance to accept the position underscores the complexities and pressures associated with leading the FDA during a time of heightened scrutiny. For industry stakeholders, these developments may indicate a shift in regulatory dynamics that could impact timelines for drug approvals and the overall landscape of biopharma innovation.
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