Diamyd Medical is a well-known biotech company based in Sweden that is working to develop an antigen-specific immunotherapy called Diamyd for type 1 diabetes. In September 2021, the US Food and Drug Administration (FDA) issued a partial US clinical hold on the phase III DIAGNODE-3 clinical trial of the drug. The FDA stated then that it did not have enough information on questions about the antigen-specific immunotherapy. Several interactions between the company and the regulatory agency have been held since then to resolve the FDA’s questions.
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