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Description

Preclinical studies, including gene therapy approaches by Abraham et al

Oncotarget 8, 7836578378

During this differentiation, the expression level of -smooth muscle actin (-SMA), a key marker, was significantly upregulated, marking the transformation of the functional characteristics of fibroblasts

While the agency has cited "significant safety risks" as the rationale behind this categorization, it has not divulged the specific methodology or details pertaining to the identified risks