Federal Register notice: CDER is proposing to refuse to approve a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets, 200 milligrams (mg) and ...
Federal Register notice: FDA announces a 4/6 advisory committee meeting to review a TransMedics PMA for its Organ Care System (OCS) Heart, a portable ...
The Government Accountability Office will testify 3/4 that FDA needs to learn lessons from the Covid-19 pandemic to improve its ability to inspect for...
FDA warns Webstore-USA that it is marketing an unapproved home serology Covid test kit.
VIR and GlaxoSmithKline say a data safety monitoring board has recommended closing the NIH Phase 3 study of their VIR-7831 Covid monoclonal antibody d...
FDA says a Phase 3 trial of BrainStorms NurOwn ALS therapy failed to demonstrate a clinical benefit.
FDA accepts for priority review an On Target Laboratories NDA for pafolacianine sodium injection as an adjunct for identifying ovarian cancer during s...
FDA clears an Asensus Surgical 510(k) for the Senhance Surgical System and its use in general surgery procedures.