专栏名称: Clindata
Clindata作为科临达康医药生物科技(北京)有限公司的注册商标,专注于肿瘤领域创新药IND到NDA全流程服务。团队在抗肿瘤临床试验设计等医学、数据管理、统计分析方面拥有二十年以上经验,完成了20个1类抗肿瘤新药IND申报和临床试验。
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重磅!FDA 正式批准1类创新药瑞德西韦用于新冠治疗!也是FDA首个获批的治疗COVID-19的新药

Clindata  · 公众号  ·  · 2020-11-04 07:53
Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospital ………………………………

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