FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic aneurysms.
FDA reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients with the superoxide ...
CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process.
Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be considered in rare disease d...
Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evi...
FDA issues a clinical hold against Athenex and Baylor College of Medicines kUR-501 after the death of a young heavily pretreated male patient.
Former CDRH Office of Compliance director Steven Silverman recommends device manufacturers look at FDAs remote regulatory assessment program as a temp...
FDA tells Sarepta Therapeutics that it has decided to hold an advisory committee meeting to review its gene therapy BLA for SRP-9001 (delandistrogene ...
