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

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

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

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

GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing ...

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

Findings from a postmarketing observational study showed an increased risk of GBS during the 42 days following vaccination.

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

On the other hand, if the FDA rejects Annexon's filing, Annexon may have to go back and revise its RWE study or even open a ...

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

GSK Plc and Pfizer Inc.’s vaccines for a common respiratory virus must carry warnings that they may be tied to an increased ...