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.
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.