FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.

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

The US Food and Drug Administration (FDA) has expanded the indication for Pfizer’s respiratory syncytial virus (RSV) vaccine ...

The FDA issued a safety communication that warns about possible Guillain-Barré syndrome (GBS) with respiratory syncytial virus (RSV) vaccines manufactured by Pfizer (Abrysvo) and GSK (Arexvy).

Pfizer's respiratory syncytial virus (RSV) vaccine Abrysvo has become the first to be approved by the FDA for use in pregnancy to protect newborns and infants from lower respiratory tract disease ...

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

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

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 ...

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 ...

As for GBS itself, this neurological ailment can be severe, attacking nerves and warranting hospitalisation for weeks or months. It can influence a variety of nerves from senses to movement, and even ...

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 ...

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 ...