Draeger Medical recalls its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of...
FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.
FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over...
FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.
FDA warns Santa Rosa, CA-based NeilMed Pharmaceuticals about CGMP and other issues in its production of finished drugs.
VeganMed asks FDA to require drug and dietary supplement manufacturers to disclose in product labeling any animal-derived ingredients in their product...
FDA approves Boston Scientifics Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulation System for treat...
FDA warns New Hope Center for Reproductive Medicine and Regenerative Labs about violations involving human cells, tissue, and cellular and tissue-base...
