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 publishes a guidance on enhanced drug distribution security at the package level.
FDA sends Satsuma Pharmaceuticals a complete response letter on its NDA for STS101 (dihydroergotamine nasal powder), an investigational product for th...
Percussionaire recalls its Distal Phasitron, part: S20020, for use with the Percussionaire VDR-4 ventilator control driver due to the potential for th...
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.
