GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Provider: View Press Release Type: Link Title: GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA | GSK Description: The US FDA has accepted a Biologics License Application and granted Priority Review for its RSV older adult vaccine candidate.
European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention
Provider: View Press Release Type: Link Title: European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention | GSK Description: The marketing application is based on results from the HPTN 083 and 084 phase IIb/III studies.
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
Provider: View Press Release Type: Link Title: GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment | GSK Description: The vaccine was well tolerated with a favourable safety profile.
GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe rheumatoid arthritis
Provider: View Press Release Type: Link Title: GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe rheumatoid arthritis | GSK Description: Full results from the ContRAst phase III programme will be submitted for publication in 2023.
GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD
Provider: View Press Release Type: Link Title: GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD | GSK Description: Daprodustat was studied in the ASCEND phase III clinical trial programme.
