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GSK’s Arexvy label expansion will intensify competition with Pfizer’s Abrysvo in RSV spaceIf accepted, Arexvy would be the first vaccine available to help protect this patient population, which would address an unmet need for high-risk adults in this age group that currently lack ...
According to the FDA, the benefits of vaccination with Abrysvo and Arexvy continue to outweigh the potential risks. The prescribing information for Abrysvo ® (respiratory syncytial virus [RSV ...
Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome. The FDA announced that it has mandated updates to the ...
FDA adds warning label to RSV vaccines Abrysvo and Arexvy about the risk for Guillain-Barré syndrome
The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information for the Abrysvo (Pfizer) and Arexvy (GlaxoSmithKline) respiratory ...
GSK has reported new clinical data pointing to a benefit with its respiratory syncytial virus (RSV) vaccine Arexvy when used to treat a younger age group than the over-60s for whom it is approved.
(RTTNews) - The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the potential risk of Guillain-Barré Syndrome following ...
the agency determined that the overall body of evidence suggested increased risks of GBS with Abrysvo and Arexvy, but that available evidence was not enough to establish a causal relationship.
The arrangement will run for three years in the first instance and, according to GSK, also “supports potential future co-development and commercialisation of Arexvy […] for adults 60 years and ...
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