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 ...
(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 ...
FDA adds warning label to RSV vaccines Abrysvo and Arexvy about the risk for Guillain-Barré syndrome
Get Instant Summarized Text (Gist) The FDA has mandated safety labeling changes for the RSV vaccines Abrysvo and Arexvy to include warnings about the risk of Guillain-Barré syndrome (GBS ...
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 ...
GSK reported a similar state of affairs Wednesday. Sales of its RSV vaccine Arexvy declined 69% year over year due to lower demand “related to a more limited recommendation ... for individuals ...
Concerns about GBS arose during the review of safety data from clinical trials prior to the approval of Abrysvo (manufactured by Pfizer) and Arexvy (manufactured by GlaxoSmithKline), according to ...
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