The Center for Veterinary Medicine issues two guidances on data element submission.
FDA says NeuroBo can start a Phase 1 trial of its DA-1726 weight loss drug.
Former FDA deputy commissioner Deborah M. Autor joins consulting group Healthcare Innovation Catalysts as chief executive officer.
FDA accepts for priority review an Adaptimmune Therapeutics BLA for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarc...
Two stakeholders respond to FDAs request for comments on using digital health technologies to detect prediabetes and undiagnosed Type 2 diabetes.
FDA clears a GE HealthCare 510(k) for its Novii+ Wireless Patch, an antepartum and intrapartum maternal and fetal monitor that measures fetal heart ra...
FDA issues a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize the regulation with i...
FDA has completed a bioresearch monitoring inspection and mid-cycle review meeting for the Abeona Therapeutics BLA for pz-cel.
