Drugs

FDA Acting Center Directors Made Permanent

CDER acting director Michael Davis and CBER acting director Karim Mikhail have both been selected as permanent directors of their respective offices.

Davis returned to FDA as CDER deputy director in 2025 after serving as Usona Institute chief medical officer for two and a half years. He left the agency in 12/2022 after serving almost seven years as a clinical team leader in CDER’s Division of Psychiatry.

Mikhail joined FDA in 2025 as a senior advisor in the Office of the Commissioner, where he led U.S. competitiveness reforms, spanning multiple disciplines from accelerating early clinical development to onshoring of biopharmaceutical manufacturing. He came to the agency with over two decades of leadership experience in leading both large pharmaceutical companies and small biotechnology startups across therapy areas including cardio-metabolism, respiratory, immunology, neuroscience, oncology, women's health, and anti-infectives.

Additionally, FDA senior advisor Jared Seehafer has been selected to serve as the agency’s first deputy commissioner for Technology and Artificial Intelligence. In his bio, he describes himself as an entrepreneur and executive with extensive experience in the regulation of medical devices and diagnostics, combination products, software, and AI. Prior to his role at FDA, he was CEO of Enzyme Corporation, a QA/RA software and services company, which he founded and led for eight years until its acquisition.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome