Browsing: FDA

The logo for the Food and Drug Administration is seen ahead of a news conference at the Health and Human…

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use…

The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative blood test with underlying technology invented at…

After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now commercially known…

If at first you don’t succeed in gene therapy, then try, try again. That’s the lesson Ultragenyx likely took home…

After three months without a permanent leader in place, President Donald Trump looks set to name a new commissioner of…

After receiving a checkered regulatory scorecard in 2024, Aurobindo’s sterile injectables and oncology unit is back in the FDA’s crosshairs.…