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FDA says it may approve returning ranitidine-containing products to the market based on new CDER research into the carcinogen NDMA...[ Price : $8.95]
FDA warns AnazaoHealth that it is compounding drugs that do not meet legal requirements and are considered to be misbranded unappr...[ Price : $8.95]
Astellas pauses screening and dosing additional participants in its ASPIRO trial of an investigational gene therapy.[ Price : $8.95]
FDA acting commissioner Janet Woodcock weighs in on the announced departures of two senior CBER vaccine officials, pledging suppor...[ Price : $8.95]
FDA clears an Asensus Surgical 510(k) to expand the machine vision capabilities of its previously cleared Intelligent Surgical Uni...[ Price : $8.95]
FDA converts Mercks accelerated approval to full approval for its anti-PD-1 Keytruda (pembrolizumab) and its use in first-line tre...[ Price : $8.95]
Attorneys Anne Walsh and JP Ellison describe changes to two Justice Department policies on using guidance documents in enforcement...[ Price : $8.95]
FDA warns Turkeys Gulsah Uretim Kozmetik Sanayi Anonim Sirketi about CGMP violations in its production of finished drugs.