U.S. government report on “notorious markets” known for counterfeiting and other violations of intellectual property says ...

Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, ...

The CDC recommends a single dose of any FDA-approved RSV vaccine for all adults ages 75 years and older, as well as for 60- ...

The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...

The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...

In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...

The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and ...

With its dwindling cash reserves set to run out this month, Windtree Therapeutics had looked like it was struggling to hold ...

The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning ...

Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...