Telix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval

Dow Jones

Mar 21, 2025

By Adriano Marchese

Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval.

The Melbrourne, Australia-based biopharmaceutical company said Friday that the Food and Drug Administration approved the new drug application for Gozellix.

Gozellix helps with advanced imaging for prostate cancer, making it easier to detect. It provides a longer shelf life and an extended distribution radius compared to existing gallium-based imaging products, Telix said.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

March 21, 2025 06:58 ET (10:58 GMT)

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It provides a longer shelf life and an extended distribution radius compared to existing gallium-based imaging products, Telix said. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  March 21, 2025 06:58 ET (10:58 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","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>Telix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval</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\">\nTelix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time\">2025-03-21 18:58</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Adriano Marchese \n</p>\n<pre>\n \n</pre>\n<p>\n  Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. \n</p>\n<p>\n  The Melbrourne, Australia-based biopharmaceutical company said Friday that the Food and Drug Administration approved the new drug application for Gozellix. \n</p>\n<p>\n  Gozellix helps with advanced imaging for prostate cancer, making it easier to detect. It provides a longer shelf life and an extended distribution radius compared to existing gallium-based imaging products, Telix said. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  March 21, 2025 06:58 ET (10:58 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"TLX.AU","symbol_name":"TELIX PHARMACEUTICALS LTD","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2521262401","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2521262401","pubTimestamp":1742554680,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval.The Melbrourne, Australia-based biopharmaceutical company said Friday that the Food and Drug Administration approved the new drug application for Gozellix.Gozellix helps with advanced imaging for prostate cancer, making it easier to detect. 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It provides a longer shelf life and an extended distribution radius compared to existing gallium-based imaging products, Telix said. \n\n\n \n\n\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  March 21, 2025 06:58 ET (10:58 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}