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 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 ...

The FDA requires labeling changes to the prescribing information for Pfizer and GSK RSV vaccines to include warnings about the risk for GBS.

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 ...

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

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 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 ...