The FDA has approved Deseyne contact lenses with extended depth of focus for the correction of presbyopia, according to a ...

FDA approvals in 2025 introduced novel therapies and devices across ophthalmic subspecialties, emphasizing sustained efficacy ...

The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

Edwards Lifesciences EW announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making ...

A strict new vaccine approval process in the U.S. could dramatically slow things down for biopharma and the public, experts ...

Edwards Lifesciences has claimed an FDA approval for its Sapien M3 transcatheter mitral valve replacement system—marking the ...

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an | With the U.

Martin Dietrich, MD, PhD, a medical oncologist at the Cancer Care Centers of Brevard and an assistant professor at the ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.