FDA曾经授予这两款药物紧急使用授权(EUA),在COVID-19疫情爆发时期,用于治疗住院COVID-19患者,这些患者无法通过加入临床试验获得治疗。 羟氯喹/氯喹能够导致QT间期延长(QT interval prolongation,指的是心电图上QT间期延长)等心率失常症状。...
4.Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19. Retrieved March 11, 2021, from https://www.gsk.com/en-gb/media/press-releases/vir-biotechnol...
参考文献 [1] https://investor.todosmedical.com/news-events/press-releases/detail/42/todos-medical-and-3dmed-enter-into-coronavirus-covid-19) [2] https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19 [3] 思路迪、华大基因、基蛋生物、亚辉龙生物官...
CTP Releases New 5-year Strategic Plan On December 18, 2023, Dr. Brian King, the Director of FDA’s Center for Tobacco Products announced the Center’s new five-year strategic plan which outlines the Center’s programmatic and workforce initiatives and includes five goals, ten outcomes, and ...
笔者根据美国FDA官网的公开信息[1],解读2023年9月获FDA药物评估和研究中心(CDER)批准上市的药物。2023年9月FDA批准上市了4个药物,包括:1)动员造血干细胞用于MM患者的自体移植的CXCR4拮抗剂(环肽);2)治疗中度或高危骨髓纤维化的JAK1/JAK2和ACVR1抑制剂(小分子);3)治疗重度抑郁症的5HT1A受体的选择性激动剂。4)...
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-lookin...
https://www.fda.gov/drugs/drug-safety-and-availability/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-tre...
虽然新型冠状病毒肺炎 (COVID-19) 紧急状态已结束 , 但新型冠状病毒 (SARS-CoV-2) 还在继续传播 ,COVID-19 对某些人来说仍然是严重的健康风险。为促进开发治疗和预防 COVID-19 的药物和生物制品,FDA 于 2024 年 2 月发布了“在 COVID-19 预防或治疗药物和生物制品临床试验中,门诊成人和青少年受试者的 ...
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statemen...
近日,FDA合规办公室发布其2023财年(2022年10月1日至2023年9月30日)年报,年报通过列举一系列图表、数字和案例,展现了合规办公室如何通过积极主动的合规策略和基于风险的执法行动,保护公众免受劣质、不安全和无效药品的侵害。本文将概述该年报的主要内容。