FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for treating first-line advanc...
Draeger Medical Systems begins a Class 1 recall of its Jaundice Meter JM-103 and JM-105 models which are used to measure bilirubin in newborn infants.
FDA permits the de novo marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney ...
FDA approves the use of Medtronics MiniMed 670G insulin delivery system in patients with Type 1 diabetes seven years of age and older.
Federal Register notice: FDA classifies the next-generation sequencing-based tumor profiling test into Class 2 (special controls).
FDA approves an Impel NeuroPharma IND for a Phase 3 clincial trial of INP104, a novel, dihydroergotamine intranasal product for treating acute migrain...
CBER releases a list of 15 guidances it plans to issue in 2018.
Federal Register notice: FDA makes available a draft guidance entitled Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Bi...