FDA approves a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcom...
Tamarack recalls Eclipse Kratom-containing powder products because they have the potential to be contaminated with Salmonella.
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Secti...
FDA issues a guidance on Chronic Obstructive Pulmonary Disease: Use of the St. Georges Respiratory Questionnaire as a Patient-reported Outcome Assessm...
FDA clears a Bioness 510(k) for the myBioness mobile app for use with its L300 Go System, a functional electrical stimulation system that offers 3D mo...
FDA clears a DarioHealth 510(k) for the companys Lightning-enabled version (Apple iPhone) of its Dario Blood Glucose Monitoring System.
An Illinois federal jury finds AbbVie liable for injuries to an Oregon man allegedly caused by the companys testosterone replacement therapy AndroGel....
FDA Review posts the Federal Register notices for the week ending 3/23/2018.