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

Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC continued to monitor for GBS risk. FDA conducted a postmarket ...

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

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

It's recommended those who are between 32 weeks and 36 weeks pregnant get one dose of the maternal RSV vaccine, Abrysvo, administered September through January. Adults 75 and older and those 60-74 ...

recommend those between 32 weeks and 36 weeks pregnant get one dose of the maternal RSV vaccine, Abrysvo, administered from September through January.

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 ...