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 ...
(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
Arexvy has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older and for those aged 50 to 59 years at increased risk.
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 ...
Vaccines sales declined 3% in 2024, reflecting pressures on Arexvy and Shingrix in the U.S. However, Arexvy remains the market leader, and international uptake is gaining momentum. Emily Field ...
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 ...
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