The Food and Drug Administration’s (FDA) chief regulator of cell and gene therapies, Nicole Verdun, has been ousted from her position after a disagreement with the director of the Center for Biologics Evaluation and Research, Vinay Prasad. According to a person familiar with the matter, Prasad canceled an advisory committee meeting to review a cell therapy developed by Capricor Therapeutics, citing skepticism about the treatment.
The move comes amid long-simmering tensions over Verdun’s management style. Others familiar with the matter suggest that her departure may be related to these issues, raising questions about the precise reason for her termination.
STAT Senior Writer Adam Feuerstein is reporting on this development and can be reached on Signal at stataf.54. Matthew Herper covers medical innovation, while Lizzy Lawrence leads STAT’s coverage of the FDA.
Source: https://www.statnews.com/2025/06/20/fda-ouster-top-gene-therapy-official-nicole-verdun-placed-on-leave-after-review-committee-canceled