FDA approves a Janssen Biotech NDA for Balversa (erdafitinib) for treating certain adult patients with locally advanced or metastatic urothelial carci...
An FDA reinspection of Alvotechs Iceland manufacturing facility results in a Form FDA-483 with one inspection finding.
Federal Register notice: FDA announces a 3/5 Medical Imaging Drugs Advisory Committee meeting to review and discuss a Lumicell NDA for pegulicianine f...
FDA approves MRI labeling on Abbotts dorsal root ganglion (DRG) stimulation therapy, the Proclaim DRG neurostimulation system.
FDA accepts for review a Novocure PMA that seeks approval for the use of tumor treating fields therapy together with standard systemic therapies for t...
FDA and CMS officials call for support of an FDA proposal to regulate laboratory-developed tests.
Federal Register notice: OMB approves an information collection entitled Institutional Review Board Waiver or Alteration of Informed Consent for Minim...
Two Axinn attorneys say there will be a flood of cases challenging federal agency decisions and interpretations of law if the Supreme Court restricts ...
