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.
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.
After showing higher efficacy and a comparable safety profile to Spikevax, the FDA has approved Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk patients.
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Guidelines from the Department of Health and Human Services recommend statins as primary prevention for people with HIV aged 40 to 75 years who have a 10-year ASCVD risk of 5% or higher.
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.