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Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate application later this year seeking a green light for the drug for the preventi","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","VNDA"],"gpt_icon":0},{"id":"2468520701","title":"UPDATE 1-U.S. FDA declines to approve Vanda's stomach paralysis drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2468520701","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2468520701?lang=en_us&edition=fundamental","pubTime":"2024-09-19 19:29","pubTimestamp":1726745375,"startTime":"0","endTime":"0","summary":"(Adds shares in paragraph 2, details on disease in paragraph 3 and 4, background in paragraphs 5-7)      Sept 19 (Reuters) - 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Vanda Pharmaceuticals Inc   :   * FDA DECLINES TO APPROVE VANDA'S MARKETING APPLICATION FOR TRADIPITANT IN GASTROPARESIS   * VANDA PHARMACEUTICALS INC - FDA ISSUES COMPLETE RESPONSE LETTER TO VANDA FOR TRADIPITANT   * VANDA PHARMACEUTICALS INC - FDA SUGGESTS ADDITIONAL STUDIES FOR TRADIPITANT APPROVAL   * VANDA PHARMACEUTICALS INC - TO SUBMIT NDA FOR TRADIPITANT IN MOTION SICKNESS LATER THIS YEAR   * VANDA: BELIEVES TRADIPITANT APPLICATION HAS MET SUBSTANTIAL EVIDENCE OF EFFICACY STANDARD   * VANDA: WILL CONTINUE TO PURSUE MARKETING AUTHORIZATION FOR TRADIPITANTSource text for Eikon:    Further company coverage:    ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["VNDA","BK4139"],"gpt_icon":0},{"id":"2468529520","title":"Vanda Pharmaceuticals Shares Down 11.3% Premarket After US FDA Declines to Approve Co's Stomach Paralysis Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2468529520","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2468529520?lang=en_us&edition=fundamental","pubTime":"2024-09-19 19:18","pubTimestamp":1726744739,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20240919:nFWN3L1020:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","VNDA"],"gpt_icon":0},{"id":"2468527462","title":"U.S. FDA declines to approve Vanda's drug for stomach paralysis","url":"https://stock-news.laohu8.com/highlight/detail?id=2468527462","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2468527462?lang=en_us&edition=fundamental","pubTime":"2024-09-19 19:08","pubTimestamp":1726744107,"startTime":"0","endTime":"0","summary":"Sept 19  - The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals'  drug for the treatment of symptoms of paralysis of the stomach, the company said on Thursday. 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to Submit Nda for Tradipitant in Motion Sickness Later This Year","url":"https://stock-news.laohu8.com/highlight/detail?id=2468352787","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2468352787?lang=en_us&edition=fundamental","pubTime":"2024-09-19 19:00","pubTimestamp":1726743609,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20240919:nTUA42NRHK:4","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["VNDA","BK4139"],"gpt_icon":0},{"id":"2468227675","title":"FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis","url":"https://stock-news.laohu8.com/highlight/detail?id=2468227675","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2468227675?lang=en_us&edition=fundamental","pubTime":"2024-09-19 19:00","pubTimestamp":1726743609,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20240919:nTUA42NRHK:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","VNDA"],"gpt_icon":0},{"id":"2468352710","title":"FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis","url":"https://stock-news.laohu8.com/highlight/detail?id=2468352710","media":"PR Newswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2468352710?lang=en_us&edition=fundamental","pubTime":"2024-09-19 19:00","pubTimestamp":1726743600,"startTime":"0","endTime":"0","summary":"WASHINGTON, Sept. 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.   today provided an update on its tradipitant development program.On September 18, 2024, the U.S. Food and Drug Administration  declined to approve Vanda's New Drug Application  of tradipitant for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter .Gastroparesis is a serious condition that is characterized by delayed gastric emptying and associated with severe nausea, vomiting, difficulty finishing a normal meal and other symptoms that have a significant impact in people's everyday living and functioning. Gastroparesis is often associated with diabetes but is also found in nondiabetic individuals and has recently been associated with the class of GLP1 inhibitors. There has been no effective treatment approved by the FDA in over 40 years.Vanda plans to submit a separate NDA for tradipitant for the prevention of vomiting in motion sickness l","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/GoZtN2oA0dsLtPL6WN74tg--~B/aD05MTt3PTQwMDthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/prnewswire.com/18f330ec7ac238d1fe3f7d2754fbd531","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/GoZtN2oA0dsLtPL6WN74tg--~B/aD05MTt3PTQwMDthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/prnewswire.com/18f330ec7ac238d1fe3f7d2754fbd531"],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/fda-declines-approve-vandas-marketing-110000957.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/fda-declines-approve-vandas-marketing-110000957.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4585","BK4121","BK4139","BK4530","CRL","BK4588","VNDA","LU0390134368.USD"],"gpt_icon":0}],"pageSize":16,"totalPage":7,"pageCount":7,"totalSize":108}]}}