George F. Tidmarsh has resigned from his job as director of the FDA Center for Drug Evaluation and Research in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.”
To say that it has been an eventful few months for George Tidmarsh would be a bit of an understatement.
FDA announced six additional awardees under the Commissioner’s National Priority Voucher pilot program, which aims to accelerate review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, Oct. 24, June 20, 2025).
On Nov. 6, FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma.
The Friends of Cancer Research annual meeting, to be held Nov. 4 in Washington, DC, will focus on three questions facing the field of oncology clinical trial design.
In a new draft guidance, FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.
Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).
In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).
Bowing to the growing animal rights movement, FDA and NIH have made policy changes to discourage animal testing, instead favoring alternative research models.
FDA has received reports of immune effector cell-associated enterocolitis in patients who received treatment with Carvykti.
