CBER Rejected Therapies Amid Staff Changes

FDA confirms Vinay Prasad, top vaccine and gene therapy official, will leave in April without a successor.
CBER rejected five cell and gene therapies, including a rare blood cancer drug, on March 6, 2026.
HHS criticized an experimental Huntington's treatment the day before CBER's rejection.
CBER management changes include staff firings and California calendar demands after a brief ouster and rehiring.
Prasad's actions led to White House intervention after refusing to review Moderna flu vaccine, shifting surveillance control.
FDA's vaccine-skeptical approach under Health Secretary Robert F. Kennedy Jr. signals broader policy changes.
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