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FDA grants full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating certain adult pati...[ Price : $8.95]
FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software that uses MRI images to conduct labeling, vi...[ Price : $8.95]
Federal Register notice: FDA makes available a publication entitled Modifications to the List of Recognized Standards, Recognition...[ Price : $8.95]
FDA says it will temporarily allow distribution of some sitagliptin products with the nitrosamine impurity NTTP above acceptable i...[ Price : $8.95]
Five stakeholders comment on an FDA draft guidance on radiolabeled mass balance studies.[ Price : $8.95]
FDA clears ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube in three sizes.[ Price : $8.95]
FDA and commissioner Robert Califf launch a new 'Rumor Control' Web page as part of the agency's first effort to address misinform...[ Price : $8.95]
Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.