STAT+: Under a new leader, the FDA’s biologics center moves to steady itself after stormy chapter

STAT PlusExclusive Under a new leader, the FDA’s biologics center moves to steady itself after stormy chapter With meetings of expert advisers and acceptance of drug submissions, CBER is showing renewed flexibility Manage alerts for this article Email this article Share this article By Lizzy LawrenceJuly 15, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. In a recent town hall meeting, Karim Mikhail told Food and Drug Administration staff that he was normal. “I am with you on planet Earth,” he said in June. “I understand very well what everybody is going through.” Advertisement Typically, such an acknowledgment would be unremarkable. But Mikhail is acting director of the FDA’s Center for Biologics Evaluation and Research, where the previous leader, Vinay Prasad, was decidedly outside the norm. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In biotechnology, drug development, FDA, HHS, Pharmaceuticals, Policy, STAT Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. Newsletter The latest updates in federal health agencies, research institutes, and U.S. policy Recommended Exclusive July 14, 2026 STAT Plus: Top Democrats question RFK Jr.’s health care advisory panel Exclusive July 13, 2026 STAT Plus: HHS presses ahead with effort to curb antidepressant use Advertisement Exclusive July 10, 2026 Nominee for key federal health role has a history of questioning vaccines Exclusive July 8, 2026 STAT Plus: In private meeting, Trump officials push to onshore generic drugmaking Exclusive June 29, 2026 STAT Plus: FDA’s top gene therapy regulator is leaving his role Subscriber Picks