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Unlike data exclusivity, ODE is market exclusivity, meaning the FDA cannot approve a competing drug for the same orphan indication during this period
GLP-1 receptor agonists carry a boxed warning regarding thyroid C-cell tumors, based on rodent studies showing increased incidence of medullary thyroid carcinoma (MTC) at high doses
Figures Abstract Background With the development of new specific inhibitors of hepatitis C virus (HCV) enzymes and functions that may yield different antiviral responses and resistance profiles according to the HCV subtype, correct HCV genotype 1 subtype identification is mandatory in clinical trials for stratification and interpretation purposes and will likely become necessary in future clinical practice
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J., Qiu, C
