U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug_老虎社区_美港股上老虎

U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug

Reuters2021-09-09

Sept 9 (Reuters) - The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the company said on Thursday.

"In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19," the company said in a statement.

Humanigen expects an ongoing study to provide additional safety and efficacy data to support its new EUA request.

The company filed its application with the FDA for emergency use of the drug in May, citing late-stage trial data.

Humanigen also started the process of UK authorization for the drug in June through a rolling review submission.

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

RyanYe
·2021-09-09
中奖了
回复
点赞
举报

热议股票

7x24

全部

关于我们·老虎社区守则·老虎社区账号管理规范·老虎社区服务协议·老虎社区隐私政策

公司名称：北京至简风宜信息技术有限公司

违法和不良信息投诉：010-5681-3562（工作时间9:30-18:30）

邮箱：service@laohu8.com

营业执照：91110105MA01A4U55R

ICP备：京ICP备18016422号

网安备：京公网安备11010502036490

关注我们

{"i18n":{"language":"zh_CN"},"data":{"share":"https://www.laohu8.com/m/news/2166316530?lang=zh_CN&edition=full","thumbnail":"","is_english":true,"pubTime":"2021-09-09 12:55","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2166316530","market":"us","top_or_hot":-1,"title":"U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug","media":"Reuters","content":"<p>Sept 9 (Reuters) - The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the company said on Thursday.</p>\n<p>\"In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,\" the company said in a statement.</p>\n<p>Humanigen expects an ongoing study to provide additional safety and efficacy data to support its new EUA request.</p>\n<p>The company filed its application with the FDA for emergency use of the drug in May, citing late-stage trial data.</p>\n<p>Humanigen also started the process of UK authorization for the drug in June through a rolling review submission.</p>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nU.S. FDA declines emergency use approval for Humanigen's COVID-19 drug\n</h2>\n\n<h4 class=\"meta\">\n\n2021-09-09 12:55 北京时间&nbsp;&nbsp;&nbsp;<strong>Reuters</strong>\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Sept 9 (Reuters) - The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the ...</p>\n\n<a href=\"None\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"HGEN","symbol_name":"Humanigen, Inc.","start_time":0,"source_url":null,"article_id":"2166316530","we_media_id":"1036604489","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2166316530","pubTimestamp":1631163354,"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1036604489","head_image":"https://static.tigerbbs.com/443ce19704621c837795676028cec868"},"summary":"Sept 9 (Reuters) - The U.S. Food and Drug Administration declined Humanigen Inc's request for emerge","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"HGEN":"Humanigen, Inc."},"translate_title":"美国食品和药物管理局拒绝对Humanigen新冠肺炎药物的紧急使用批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"HGEN":0.9},"content_text":"Sept 9 (Reuters) - The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the company said on Thursday.\n\"In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,\" the company said in a statement.\nHumanigen expects an ongoing study to provide additional safety and efficacy data to support its new EUA request.\nThe company filed its application with the FDA for emergency use of the drug in May, citing late-stage trial data.\nHumanigen also started the process of UK authorization for the drug in June through a rolling review submission.","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[{"id":883068313,"gmtCreate":1631190393232,"gmtModify":1631190393232,"author":{"id":"3494524945898080","authorId":"3494524945898080","name":"RyanYe","avatar":"https://static.tigerbbs.com/bbd18b884a4e5ccdb7802012080e0305","vip":1,"crmLevel":1,"crmLevelSwitch":0},"htmlText":"中奖了","listText":"中奖了","text":"中奖了","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/883068313","repostId":2166316530,"repostType":2,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"}],"hasMoreComments":true,"newsSizeData":{"likeSize":19,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false}}