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(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to ...
Arexvy is currently approved to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older, and those 50 to 59 years of age who are at increased risk for LRTD ...
London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend ...
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Pharmaceutical Technology on MSNGSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patientsThe label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...
GSK announces US FDA accepts application to review expanded use of RSV vaccine, Arexvy for adults 18-49 at increased risk: London, UK Wednesday, July 16, 2025, 14:00 Hrs [IST] GSK ...
GSK's major growth drivers, Shingrix and Arexvy, along with recent legal progress, make its current undervaluation unjustified. See what to expect from GSK's Q3.
The European Commission approves GSK's RSV vaccine, Arexvy, for use in adults aged 50-59 years with increased risk of the disease.
GSK announces positive topline data on co-administration of AREXVY and SHINGRIXTrial met primary endpoint, non-inferior immune response for both vaccines when co-administered compared with ...
OPEN The FTSE 100 was expected to open 9.7 points lower ahead of the bell on Monday after wrapping up the previous session 0.38% softer at 8,941.12.
GSK had expected Arexvy to be a blockbuster product, estimating peak annual sales of 3 billion pounds, but sales have missed market expectations for several quarters.
"A regulatory decision by the FDA on this submission is expected in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic ...
The offering, the first IPO this year, attracted more than 32 billion dirhams ($3.5 bln) in demand for 500 million dirhams in shares. GSK seeks FDA nod for expanded use of RSV vaccine in adults ...
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