Sanofi Eyes First On-Body Injector Cancer Therapy As FDA Delays Decision

Benzinga_recent_news04-22

The U.S. Food and Drug Administration (FDA) on Wednesday delayed its decision on Sanofi SA’s (NASDAQ:SNY) subcutaneous Sarclisa formulation while separately broadening the eligible patient population ...

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Regulators previously approved it for patients aged eight years and older.\nThe agency granted the approval under priority review and backed it with data from the PETITE-T1D phase 4 study, which evaluated safety and pharmacokinetics in younger children.\nTzield remains the first disease-modifying therapy indicated for delaying disease progression in early-stage type 1 diabetes and is also under FDA review for an additional use in newly diagnosed stage 3 patients aged eight and older.\nSNY Stock Price Activity: Sanofi shares were up 0.87% at $47.54 during premarket trading on Wednesday, according to Benzinga Pro data.\nImage via Shutterstock\nTo add Benzinga News as your preferred source on Google, click here.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2629043035","isCrawlerRequest":true}