Public Citizen says FDA should disqualify from conducting clinical trials two doctors at the Hennepin County Medical Center and the centers institutio...
FDA grants fast track designation to AstraZenecas hyperkalemia drug Lokelma to reduce arrhythmia-related cardiovascular outcomes in patients on chroni...
Cook Group recommends improvements to an FDA draft guidance on the electronic submission eSTAR template.
FDA grants Blackrock Neurotech a breakthrough device designation for its MoveAgain Brain Computer Interface System that is intended to provide immobil...
CytoDyn begins resubmitting a rolling BLA for leronlimab, a CCR5 antagonist used in combination therapy with highly active antiretroviral therapy for ...
FDA says it is asking the Model-Informed Drug Development meeting requests and packages to include a credibility framework.
The journal Nature explores researchers questions about how FDA will act on two new amyloid-β therapies for Alzheimers disease, given its experie...
Researchers say FDA and NIH could do more to enforce ClinicalTrials.gov reporting requirements.