Vanda Pharmaceuticals sues FDA seeking a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon)...
Former CBER director Peter Marks tells Time that he was seeing an increasing anti-vaccine tone before he resigned from the agency over pressure from t...
FDA approves an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) f...
FDA grants Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, for protecting against H5N1 influ...
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) and Yervoy (ipilimumab) for combination first-line treatment of adult patients with unresectable...
U.S. senator Rand Paul (R-KY) introduces legislation to streamline the approval process for biosimilars by eliminating costly and redundant clinical s...
An address to FDA staff at the White Oak, MD campus by HHS secretary Robert F. Kennedy Jr. diverts to Deep State rhetoric and accusations about agency...
Daxor Corp. submits a 510(k) seeking FDA clearance for its next-generation blood volume analyzer.
