Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet primary and secondary e...
FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical device software functions...
FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.
FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline ...
FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.
FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.
