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

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 ...

More than half (53%) of patients reached remission after one year of Omvoh treatment and 46% experienced healing of the ...

In addition to reporting 2024 revenue at the lower end of its previous guided range, Moderna issued a disappointing forward ...

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

In this note, while we briefly touch upon Pfizer’s performance in 2024, we focus on the impact on PFE stock and how 2025 ...

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

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

The FDA granted priority review designation to J&J’s biologics license application (BLA) seeking approval of nipocalimab for antibody-positive patients with gMG, a rare, autoantibody-driven disease.

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

On Tuesday, January 7, the FDA announced it would now be requiring GSK and Pfizer’s RSV vaccines to hold warnings of a risk of Guillain-Barré syndrome (GBS). This is after post market analysis by the ...