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FDA:2021年新药年度报告-26页

# 新药 大小:0.65M | 页数:26 | 上架时间:2022-01-11 | 语言:英文
FDA:2021年新药年度报告-26页.pdf

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类型: 行研

上传者: FF

撰写机构: FDA

出版日期: 2022-01-07

摘要:

In 2021, CDER approved many different drug therapies, helping patients have a better quality of life, reducing disease symptoms or severity, and in many instances, protecting patients against life-threatening illnesses.  

In 2021, CDER took important steps in advancing treatment options for patients with diabetes. CDER approved several diabetes medications, including one interchangeable biosimilar insulin product and one biosimilar insulin product, which can provide patients with additional safe, high-quality, and potentially more cost-effective options. CDER also approved a treatment for pediatric patients ages 10 and older with type 2 diabetes and a therapy for severe hypoglycemia, or low blood sugar, in patients aged six years and older with diabetes.  

We approved a therapy to reduce the risk of serious complications in adults with chronic kidney disease associated with type 2 diabetes. In addition, we approved a treatment to reduce the risk of serious outcomes in adults with chronic kidney disease at risk of chronic kidney disease progression.  

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