FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
UniQure said the U.S. Food and Drug Administration no longer agreed that clinical data for the Dutch company's gene therapy for Huntington's disease may be adequate for a marketing application, ...
The director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, George Tidmarsh, resigned on Sunday amid serious concerns about his personal conduct, a Department of ...
November 3, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced ...
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FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government ...
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