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875,230 Results for "center for biologics evaluation and research cber".
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Government
Prasad ally Szarama exits CBER after 3 weeks as FDA cleanout continues
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.
May 18, 2026
·
2 min read
·
Tristan Manalac
FDA
FDA taps Szarama as acting CBER director as Prasad’s tumultuous tenure ends
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.
May 1, 2026
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2 min read
·
Heather McKenzie
Opinion
Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust
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.
April 24, 2026
·
5 min read
·
Joshua R. Mansbach
Regulatory
Acting CBER, CDER heads become permanent as FDA works to restore stability
The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton, President Donald Trump’s nominee for commissioner.
September 9, 2026
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2 min read
·
Tristan Manalac
Government
FDA uncertainty persists as search for Prasad successor at CBER drags on
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.
May 5, 2026
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2 min read
·
Tristan Manalac
FDA
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
The FDA’s primary review team found that Replimune hadn’t sufficiently addressed deficiencies that had been pointed out in the two prior rejection letters for the melanoma therapy Tudriqev.
September 3, 2026
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2 min read
·
Tristan Manalac
FDA
FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief
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.
March 6, 2026
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3 min read
·
Heather McKenzie
Press Releases
Allegheny Health Network and The START Center for Cancer Research Announce Strategic Collaboration to Expand Patient Access to Early-Phase Cancer Trials
New START site to be established within AHN Cancer Center will integrate novel oncology research therapies closer to patients across Western Pennsylvania
August 25, 2026
·
1 min read
FDA
FDA’s cell and gene therapy head steps down after 1 year
Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.
June 30, 2026
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2 min read
·
Michael Gibney
FDA
Prasad Back at CBER After 10-Day California ‘Vacation’
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.
August 9, 2025
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2 min read
·
Heather McKenzie
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