We are confident that we will resolve the matters outlined in the warning letter to the FDAs full satisfaction. The FDA has issued other warnings and communications to Novo recently, including one in September 2025 for deceptive and misleading advertising linked to its semaglutide products, and an inspection report made public in August 2025 flagging violations at a manufacturing plant in Indiana.
After a 1-week acclimatization period, mice were intraperitoneally injected with STF-31 (GLUT1-specific inhibitor) at a dose of 7.8 mg/kg once daily for 3 days
This CDE guidance emphasized an appropriate selection of the test system, whether it is in vitro or in vivo or an alternative toxicity testing method, and also reminded to carefully choose the dose and testing time period
A holistic health clinic focuses on treating the whole person rather than isolated symptoms
Following treatment medium was replaced and cell viability was assessed after 16 h (Naisbitt et al., 1998) by the resazurin reduction assay as described before (Sison-Young et al., 2017)