FDA accepts for review Obseva's linzagolix application for uterine fibroids_老虎社区_美港股上老虎

FDA accepts for review Obseva's linzagolix application for uterine fibroids

seekingalpha2021-11-22

Obseva(NASDAQ:OBSV)announces that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted...

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YauDK
·2021-11-22
Oh ye ye
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- MightyPooP:
  ok
  2021-11-22
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SimaWuqin
·2021-11-22
It is time! gogo
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- gl8089:
  nice
  2021-11-22
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management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted...</p>\n\n<a href=\"https://seekingalpha.com/news/3773107-fda-accepts-for-review-obsevas-linzagolix-application-for-uterine-fibroids\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"source_url":"https://seekingalpha.com/news/3773107-fda-accepts-for-review-obsevas-linzagolix-application-for-uterine-fibroids","is_english":true,"share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","article_id":"1150150145","content_text":"Obseva(NASDAQ:OBSV)announces that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the U.S. FDA.\nThe submission is based on data from the two Phase 3 PRIMROSE trials.\nThe FDA has set a target action date of September 13, 2022 for this NDA under PDUFA.\nLinzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.\nLast month, Obseva inked partnership with Syneos Health to support commercialization of linzagolix in U.S. and EU.\nOBSV submitted linzagolix NDA in U.S. for uterine fibroids in September 2021.","news_type":1},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":6678119,"gmtCreate":1637578243818,"gmtModify":1637578243854,"authorId":3575163551534398,"author":{"id":3575163551534398,"idStr":"3575163551534398","authorId":3575163551534398,"name":"MightyPooP","avatar":"https://static.tigerbbs.com/aec66d00ca2b1f2b75412008d93edd14","vip":1,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":872723571,"type":1,"supId":0,"prevId":0,"content":"<u>ok</u>","text":"<u>ok</u>","html":"<u>ok</u>"}],"langContent":"CN"},{"id":872784096,"gmtCreate":1637575426515,"gmtModify":1637575426515,"author":{"id":"3568459082756365","authorId":"3568459082756365","name":"SimaWuqin","avatar":"https://static.tigerbbs.com/6bc36ec0fc750ba6d2fd4bb2d77c4c09","vip":1,"crmLevel":5,"crmLevelSwitch":0,"idStr":"3568459082756365","authorIdStr":"3568459082756365"},"htmlText":"It is time! gogo","listText":"It is time! 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PRIMROSE trials.</p>\n<p>The FDA has set a target action date of September 13, 2022 for this NDA under PDUFA.</p>\n<p>Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.</p>\n<p>Last month, Obseva inked partnership with Syneos Health to support&nbsp;commercialization of linzagolix in U.S. and EU.</p>\n<p>OBSV submitted&nbsp;linzagolix NDA in U.S. for uterine fibroids in September 2021.</p>","source":"seekingalpha","collect":0,"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>FDA accepts for review 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the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted...</p>\n\n<a href=\"https://seekingalpha.com/news/3773107-fda-accepts-for-review-obsevas-linzagolix-application-for-uterine-fibroids\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"source_url":"https://seekingalpha.com/news/3773107-fda-accepts-for-review-obsevas-linzagolix-application-for-uterine-fibroids","is_english":true,"share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","article_id":"1150150145","content_text":"Obseva(NASDAQ:OBSV)announces that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the U.S. FDA.\nThe submission is based on data from the two Phase 3 PRIMROSE trials.\nThe FDA has set a target action date of September 13, 2022 for this NDA under PDUFA.\nLinzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.\nLast month, Obseva inked partnership with Syneos Health to support commercialization of linzagolix in U.S. and EU.\nOBSV submitted linzagolix NDA in U.S. for uterine fibroids in September 2021.","news_type":1},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":6677984,"gmtCreate":1637577073173,"gmtModify":1637577073203,"authorId":3564973527542193,"author":{"id":3564973527542193,"idStr":"3564973527542193","authorId":3564973527542193,"name":"gl8089","avatar":"https://static.laohu8.com/default-avatar.jpg","vip":1,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":872784096,"type":1,"supId":0,"prevId":0,"content":"<u>nice</u>","text":"<u>nice</u>","html":"<u>nice</u>"}],"langContent":"CN"}],"hasMoreComments":true,"newsSizeData":{"likeSize":45,"commentSize":2,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false}}