FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.
FDA approves both Breakthrough Device and Targeted Acceleration Pathway designations for Phantom Neuros Phantom X platform that controls prosthetic li...
FDA commissioner-nominee Marty Makary pledges during his confirmation hearing to do an independent assessment on personnel before recommending if any ...
FDA issues a medical device early alert on a Baxter recall of specified Spectrum infusion pumps.
The Trump Administration reverses an Elon Musk decision to terminate the lease of a 52,000 square foot major FDA laboratory in St. Louis, MO.
FDA grants orphan drug designation to Farons bexmarilimab to treat myelodysplastic syndrome.
FDA accepts for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis.
An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with serious adverse events...