US FDA Approves GSK's AREXVY, the World's First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
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GSK plc (LSE/NYSE: GSK) today announced the publication of positive phase III trial results for its respiratory syncytial virus (RSV) older adult vaccine candidate in the New England Journal of Medicine. The publication summarises the pivotal efficacy data (previously presented at IDWeek 2022), showing the vaccine .
/CNW/ - GSK has filed a New Drug Submission (NDS) to Health Canada for its respiratory syncytial virus (RSV) older adult vaccine candidate. If approved, GSK s.
US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023 This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan Vaccine candidate has the potential to be the first available to help protect adults aged 60 years and older from lower respiratory tract