Vijay Kumar, the FDA's leading gene therapy regulator, has departed his post. His exit is the latest in a series of leadership changes at the agency.
The departure follows a broader leadership shakeup at the FDA, though specific reasons for Kumar's exit were not detailed in the source. Gene therapy oversight faces uncertainty as a result.
No specific timeline or successor has been named. The source did not provide additional statistics or concrete details about the timing or impact of the move.
The shakeup could affect the review pipeline for gene therapies, though the exact implications remain unclear. Industry observers will watch for further announcements.
More information may emerge as the FDA clarifies its regulatory leadership structure.