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FDA cited the lack of adequate safety and efficacy data, the absence of an approved application, and insufficient evidence of a clinical need that could not be met by an approved product

It is one of the most important vitamins in maintaining the nervous system, and also plays a crucial role in a variety of bodily processes, including: Normal functioning of the brain and nervous system Cognitive functioning (ability to think) Formation of red blood cells and anemia prevention Helping create and regulate DNA Helping protect the eyes from macular degeneration Energy production B12 is naturally found in: Meat and liver Fish Clams Milk and dairy products Eggs It can be difficult for some people to meet their vitamin B12 requirements

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They add that as immunotherapies are being more commonly utilized as first- and second-line treatments, immunotoxicity and autoimmunity are emerging as the Achilles heel of immunotherapy. In their Cancer Immunology Research paper, Bluestone and colleagues briefly discuss immunotherapeutic strategies that can potentially prevent irAEs, such as targeting intratumoral T cells directly, using bispecific antibodies to enhance localized targeting of tumor, and using engineered cell therapies to fine-tune immune cell responses

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