Dr. Nicole Verdun placed on leave at FDA

EXCLUSIVE: STAT takes you inside the FDA to explain the ouster of Nicole Verdun, the agency's chief regulator of cell and gene therapies. Centered around disagreements over Capricor $CAPR Duchenne therapy and Verdun's management style www.statnews.com/2025/06/20/fda-ouster-top-gene-therapy-official-nicole-verdun-placed-on-leave-after-review-committee-canceled/

Along with loss of other senior FDA staff, this is a significant setback for cell gene therapy. The advent of these advances was one of Pres Trump's first term triumphs, along with his efforts to expand access to them. The field now faces a harder future www.statnews.com/2025/06/18/top-gene-therapy-regulator-forced-out-at-fda/

Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official Nicole Verdun Tensions had been high before a top gene therapy regulator was placed on leave, alarming industry By @adamfeuerstein, me, @Jasonmmast and @LizzyLaw_

Stayed at BIO today largely because Nicole Verdun was scheduled to be here ...then this happened... insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-top-cell-and-gene-therapy-regulators-forced-out-CJPZRHPMRFBENIBFRGA7JBXKGA/