pharmaphorum7d
Plants and vaccine adjuvants: BSI’s sustainable trees in a lab
Arexvy for RSV, Novavax’s COVID-19 vaccine, and others. “We’re a pretty new company to the space of vaccine adjuvants, but we have demonstrated that we have a technology that is scalable ...
Medical Xpress23d
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.
Business Insider28d
FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV Vaccines Abrysvo And Arexvy
(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 ...
FiercePharma29d
RSV vaccines from Pfizer, GSK take another hit with new FDA warning mandate
The ruling will affect GSK’s Arexvy and Pfizer’s Abrysvo, both of which were approved by the agency in May of 2023 for adults 60 years or older and realized booming sales in their first year ...
infectiousdiseaseadvisor.com3d
Prefilled Syringe Presentation of Shingrix Under FDA Review
The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
Healio29d
FDA says RSV vaccines must come with Guillain-Barré warning
Image: Adobe Stock “FDA has determined that the overall body of evidence suggests increased risks of [Guillain-Barré] with Abrysvo and Arexvy, but that available evidence is insufficient to ...
Renal & Urology News22d
RSV Vaccine Labeling Updated With Guillain-Barré Syndrome Warning
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 ...
Benzinga.com29d
Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder
The FDA identified an estimated 9 excess GBS cases per million doses for Pfizer's Abrysvo and 7 excess cases per million for GSK's Arexvy. Updated warnings stem from Medicare-based studies ...
Pharm Exec28d
FDA Mandates Updates to Prescribing Information for RSV Vaccines Abrysvo, Arexvy for Increased Guillain-Barré Syndrome Risk
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 ...
MedPage Today29d
FDA Adds Guillain-Barre Syndrome Warning to Two RSV Vaccines
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The ...
Medscape15d
RSV Vaccines Will Carry Warning for Guillain-Barré Syndrome
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 ...