Draeger Medical recalls its Carina Sub-Acute Care Ventilators due to the presence of contaminants in the devices airpath.
Rep. Debbie Dingell asks FDA and CDC to answer questions about recent cases of tuberculosis linked to contaminated Aziyo Biologics bone grafts.
Three stakeholders make suggestions to an FDA draft guidance on efficacy endpoints in clinical trials for antidiabetic drugs.
Lilly says its Retevmo met the primary progression-free survival endpoint in a clinical trial in patients with RET-mutant medullary thyroid cancer.
FDA clears a Welldoc 510(k) for its BlueStar diabetes digital health device that provides bolus insulin dose recommendations based on readings from co...
FDA grants Nexcella an orphan drug designation for its CAR-T cell therapy NXC-201 for treating multiple myeloma.
FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.
Federal Register notice: FDA announces a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for Lumakras (sotorasib)...
