WASHINGTON, D.C. — Dr. Vinay Prasad, the FDA’s top vaccines and biologics regulator, will leave the agency at the end of April, a move announced by FDA Commissioner Marty Makary. We are emphasizing points confirmed across multiple reputable sources, including The Associated Press, Reuters, CNBC, NPR, and The Guardian.

  • Prasad will depart at the end of April and return to his academic post at the University of California, San Francisco.
  • Makary told FDA staff a successor will be named before Prasad leaves the agency.
  • This is Prasad’s second exit from the role in less than a year after a brief July departure and subsequent return.
  • His tenure has been marked by disputes over how the FDA reviews vaccines, gene therapies, and other specialty drugs.

Additional Details Reported

One flashpoint was the FDA’s initial refusal to review Moderna’s application for a new mRNA-based flu vaccine, a decision the agency later reversed.

Another dispute involved UniQure’s experimental Huntington’s disease gene therapy, with regulators insisting on a new study and the company pushing back on the scope of the request.

Prasad was appointed director of the Center for Biologics Evaluation and Research in May 2025 and returned after a short initial departure tied to questions about regulatory handling of rare disease treatments.


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