George Tidmarsh, the director of FDA’s Center for Drug Evaluation and Research, publicly questioned the safety and clinical benefit of voclosporin, a 2021-approved drug for lupus nephritis, on his personal LinkedIn. Tidmarsh highlighted concerns over significant toxicity and insufficient evidence demonstrating direct patient benefit. This rare, candid critique from a senior FDA official sparked speculation and debate across biotech investor circles about regulatory perspectives on the drug. The post delves into implications for drug approval standards and patient safety.