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 reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients with the superoxide ...
FDA accepts for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressive.
FDA tells Sarepta Therapeutics that it has decided to hold an advisory committee meeting to review its gene therapy BLA for SRP-9001 (delandistrogene ...
FDA issues Olympus Medical Systems a Warning Letter after inspecting the firms Tokyo facility and documenting GMP deficiencies.
A federal judge approves a $25 million class action settlement involving Johnson & Johnsons Remicade (infliximab).
