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Accepts NDA for TLX101-Px (Pixclara®)","url":"https://stock-news.laohu8.com/highlight/detail?id=2626156814","media":"prnewswire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2626156814?lang=en_us&edition=fundamental","pubTime":"2026-04-10 06:50","pubTimestamp":1775775000,"startTime":"0","endTime":"0","summary":"MELBOURNE, Australia and INDIANAPOLIS, April 10, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited  today announces that the United States  Food and Drug Administration  has accepted the Company's resubmitted New Drug Application  for TLX101-Px[1], , an investigational PET[3] agent for the imaging of glioma , and has assigned a PDUFA[4] goal date of September 11, 2026.The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients[5]. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines[6] – and TLX101-Px has been granted Orphan Drug[7] and Fast Track[8] designations by the FDA.Patrick Wen, MD, E. Antonio Chiocca,MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added, \"Distinguishing tumor progression from treatment-related c","market":"us","thumbnail":"https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.jpg?w=300","type":0,"news_type":0,"thumbnails":["https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.jpg?w=300"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.prnewswire.com/apac/news-releases/fda-accepts-nda-for-tlx101-px-pixclara-302738824.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["TLX","ASX.AU","CNS","BK4139","BK4585","BK7104","SEC.AU","BK4543","BK4135","BK4588","BK7039","BK7067","BK4141","GBM.AU","LABU","TLX.AU","BK4526","ASX"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2624547779","title":"Telix Appoints David Gill as Non-Executive Director","url":"https://stock-news.laohu8.com/highlight/detail?id=2624547779","media":"prnewswire","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2624547779?lang=en_us&edition=fundamental","pubTime":"2026-04-02 06:59","pubTimestamp":1775084340,"startTime":"0","endTime":"0","summary":"Mr. Gill brings deep expertise in capital markets, scaling businesses, governance and corporate turn-around strategy and has served as Chief Financial Officer or President of multiple publicly traded companies, including EndoChoiceHoldings, Inc. , INC Research , and CTI Molecular Imaging . He holds a B.S. in Accounting from Wake Forest University and an MBA from Emory University.Telix Interim Chair, Mark Nelson, commented, \"We are pleased to welcome David to the Board, where his strong financial expertise and deep knowledge of U.S. capital markets will be highly valuable. We intend to further strengthen the Board through additional appointments aligned with our growth trajectory and governance needs as a dual-listed company.\". Telix Investor Relations Ms. Charlene JawAssociate Director Investor Relations[emailprotected]","market":"fut","thumbnail":"https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.jpg?w=300","type":0,"news_type":0,"thumbnails":["https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.jpg?w=300"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.prnewswire.com/apac/news-releases/telix-appoints-david-gill-as-non-executive-director-302732101.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["QYLG","TLX.AU","BK4526","QQQY","ASX.AU","FTEC",".IXIC","IYW","INCR","BK4543","EOLS","BK4141","SQQQ","YMAB","BK4007","QID","QQQM","TQQQ","JEPQ","NDX","QQQE","GPIQ","TLX","BK7039","SBBP","SEC.AU","BK7067","NVIW.SI","QDTE","NQmain","BK4139","PSQ","ASX","QQQJ","MNQmain","QQQ","QLD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2623554843","title":"Taiwan Dual-Listings Monitor: TSMC Premium Compresses; 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