The FDA has approved Moderna’s mRESVIA vaccine for adults aged 18 to 59 who are at increased risk for RSV, expanding its indication beyond older adults.
The FDA has approved enflonsia, a fixed-dose monoclonal antibody, for preventing RSV lower respiratory tract disease in infants during their first season.
May’s FDA approvals include the first at-home HPV test, a blood-based Alzheimer’s diagnostic, biosimilars, AI-enabled imaging tools, and novel therapies across cardiology, pulmonology, neurology, gastroenterology, and more.
The FDA has approved Abbott’s Tendyne system, the first transcatheter mitral valve replacement for patients with severe mitral annular calcification who are ineligible for open-heart surgery.