Getting FDA approval is just the first ... in the US in adults aged 65 years and older each year. The scale of the problem has led analysts to predict that the market for RSV vaccines could ...
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
the FDA noted. RSV is a major cause of hospitalization among older adults, particularly those aged older than 75 years. The shots made by GSK and Pfizer were the first RSV vaccines ever approved ...
The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines ... of which were approved by the agency in May of 2023 for adults 60 years or ...
After approval ... risk in adults ages 50 and older vaccinated with Arexvy. The FDA further determined that the benefits of vaccination with the two RSV vaccines continue to outweigh their ...
For each vaccine ... has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older and for those aged 50 to 59 years at ...
In the pivotal MATISSE trial, the vaccine was around 82% effective at preventing any MA-LRTD caused by RSV in the first three ... of a likely FDA approval of its RSV vaccine in adults aged over ...
Revenue for Arexvy and Abrysvo fell sharply year over year in the fourth quarter due to narrower U.S. guidelines for their use.
The FDA evaluated the association between the vaccines ... was first approved on May 3, 2023, for the prevention of LRTD caused by RSV in individuals 60 years of age and older. Since then, it has also ...
Since 2023, vaccines are now available and are highly recommended, especially for older adults. Respiratory ... were born during or are entering their first RSV season (fall to spring) children ...
Despite 50 years ... component of an RSV vaccine. The F protein exists as a trimer in both prefusion and postfusion forms that can elicit neutralizing antibodies. The US FDA-approved monoclonal ...