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After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.

Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

The FDA is reportedly down to a handful of final candidates to lead CBER, with a potential selection expected in the coming month or two. For now, the appointment of acting director Katherine Szarama has not allayed the industry’s concerns.

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle feathers in biopharma after presiding over the rejection of several rare disease therapies.

Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.

After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.

First quarter earnings continue to arrive, with analysts demanding more from cautious Pfizer and Eli Lilly expecting more revenue; the FDA taps Katherine Szarama as Vinay Prasad’s controversial FDA tenure ends; oncology veterans miss Richard Pazdur at the agency’s first adcomm in nine months; and QurAlis and Corcept Therapeutics spark renewed hope in ALS.

The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.

Capricor Therapeutics’ deramiocel was rejected in July 2025, potentially caught between Nicole Verdun, a former top biologics regulator at the FDA, and outgoing Vinay Prasad, director of the Center for Biologics Evaluation and Research.