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Nine Republican senators press FDA to increase its foreign inspections of medical product manufacturing facilities.[ Price : $8.95]
FDA accepts for priority review an Amgen BLA for tarlatamab for treating certain adult patients with advanced small cell lung canc...[ Price : $8.95]
AdvaMed faults FDA for not approving an extension to the comment deadline on three 510(k) guidances issued in September concerning...[ Price : $8.95]
Syndax Pharmaceuticals plans an NDA submission by year end for revumenib, a first-in-class menin inhibitor for treating patients w...[ Price : $8.95]
Federal Register notice: FDA posts a summary of the comments received for the Methodological Challenges Related to Patient Experie...[ Price : $8.95]
The U.S. Supreme Court agrees to hear arguments in an appeal of the 5th Circuit Court of Appeals decision that places restrictions...[ Price : $8.95]
FDA says it is creating a nine-member Genetic Metabolic Diseases Advisory Committee.[ Price : $8.95]
Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and relate...