GSK
3 years ago ⋅ English ⋅ 3 min read
Newsroom
GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

For media and investors only- 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... Read More
GSK
3 years ago ⋅ English ⋅ 4 min read
Newsroom
GSK delivers strong Q3 2022 sales of £7.8 billion +18% AER, +9% CER and Total EPS 255.9p +>100% AER, +>100% CER; Adjusted EPS of 46.9p +25% AER, +11% CER

GSK delivers strong Q3 2022 sales of £7.8 billion +18% AER, +9% CER and Total EPS 255.9p +>100% AER, +>100% CER; Adjusted EPS of 46.9p +25% AER, +11% CERFor media and invest... Read More
GSK
3 years ago ⋅ English ⋅ 5 min read
Newsroom
European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention

For media and investors only- The marketing application is based on results from the HPTN 083 and 084 phase IIb/III studies in which the injectable medicine, given as few as six times p... Read More
GSK
3 years ago ⋅ English ⋅ 2 min read
Newsroom
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment

For media and investors only- Application based on positive pivotal phase III data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract disease in adults... Read More
GSK
3 years ago ⋅ English ⋅ 2 min read
Newsroom
GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe rheumatoid arthritis

For media and investors onlyGSK plc (LSE/NYSE: GSK) today provided an update on the ContRAst phase III programme for otilimab, an investigational monoclonal antibody targeting granulocy... Read More
GSK
3 years ago ⋅ English ⋅ 5 min read
Newsroom
GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD

For media and investors onlyGSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported that... Read More