STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging

Is George Tidmarsh, the Food and Drug Administration’s top regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? 

It’s the question biotech investors were wagging about all Monday after Tidmarsh used his personal LinkedIn page to raise questions about the safety of voclosporin, a rather obscure drug the FDA approved in 2021 to treat patients with lupus nephritis, a type of autoimmune disease that damages the kidneys. 

Voclosporin has “significant toxicity,” Tidmarsh wrote in his LinkedIn post, adding that the drug “has not been shown to provide a direct clinical benefit for patients.” 

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