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FDA Advisory Committee Meeting Scheduled For October 28, 2022 To Review Y-mAbs' Refiling For Omburtamab
Thursday, September 1, 2022 - 5:42pm | 212Read More...The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review Y-mAbs Therapeutics’ (NASDAQ: YMAB) Biological License Application (BLA) for its product candidate, OMBLASTYS (omburtamab) for pediatric patients with...
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FDA AdComm Votes Against Lilly's Lung Cancer Drug, Sintilimab
Friday, February 11, 2022 - 3:54pm | 298Read More...The FDA advisory committee voted against the full approval of Eli Lilly And Co's (NYSE: LLY) lung cancer treatment over concerns that the clinical trial was conducted only in China and that its results did not apply to U.S. patients. The monoclonal antibody treatment sintilimab...
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SunTrust's Latest Comments On Merck
Wednesday, April 15, 2015 - 3:32pm | 285Read More...In a report published Tuesday, SunTrust Robinson Humphrey analyst John Boris discussed the FDA AdCom's vote to add safety warnings to AstraZeneca plc (NYSE: AZN)'s Onglyza and Takeda's Nesina, which is a positive for Merck & Co., Inc. (NYSE: MRK)'s Januvia franchise. The FDA AdCom voted that...
