Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus ...

This week, the FDA granted priority review status to J&J’s JNJ application seeking approval of key pipeline candidate ...

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

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 will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning ...

The change was prompted by postmarketing observational studies that suggest an increased risk of GBS within 42 days of ...

A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s ...

FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk.

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 ...

Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

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

The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and ...