Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC ...

The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information ...

The prescribing information for Abrysvo ® (respiratory syncytial virus [RSV] vaccine) and Arexvy ® (RSV vaccine, adjuvanted) has been updated to include a new warning regarding the risk of ...

The prescribing information for two respiratory syncytial virus (RSV) vaccines will now include a warning for the increased ...

FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk. Study estimates 7-9 excess GBS cases per million doses.

The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the ...

The FDA has mandated updated safety labeling for two respiratory syncytial virus vaccines, Pfizer's Abrysvo and GlaxoSmithKline's Arexvy, following the identification of an increased risk of ...

A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments ...

As for GBS itself, this neurological ailment can be severe, attacking nerves and warranting hospitalisation for weeks or ...

As part of the vaccine approval process, the FDA required Pfizer to conduct a study to evaluate the risk of GBS among adults vaccinated with Abrysvo in the U.S. in all age groups for which 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 ...

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 ...