Cook Group recommends improvements to an FDA draft guidance on the electronic submission eSTAR template.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.
FDA authorizes the de novo marketing of AppliedVRs EaseVRx, a prescription-use immersive virtual reality system that uses cognitive behavioral therapy...
FDA grants Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.