FDA accepts GSK's filing to extend Arexvy's RSV vaccine use to high-risk adults under 50, with a decision due in 2026.

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

The update covers the safety and appropriate timing of vaccinations, screening for osteoporosis, cervical cancer, skin cancer ...

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

The CDC already recommends the RSV shot for all adults 75 and older and for people 60 and older who have health conditions that increase their risk of severe RSV. It also recommends the shot during ...

GSK specialty medicines grew YoY in Q1 2025, and it is now the main profit engine, offsetting the weakness in their vaccine ...

It is a mistake to claim that there is not widespread research into the effectiveness of vaccines, especially those given to ...

The agency's website indicates HHS Secretary Robert F. Kennedy Jr. adopted the previous advisory panel's suggestion to expand access on June 25. AP also reports on FDA vaccine chief Vinay Prasad's ...

Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are ...