Agile Therapeutics says it will appeal an ODE3 director decision denying its appeal of a complete response letter for its Twirla once-weekly contracep...
FDA approves an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patient...
FDA commissioner Scott Gottlieb tells a House hearing that more focus is being placed on modernizing clinical trials.
FDA clears a PerkinElmer 510(k) for its EuroImmun ANCA IFA and Europlus Granulocyte Mosaic assays and their use with the EuroPattern microscope.
Federal Register notice: FDA announces a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketp...
FDA places a clinical hold on a Sarepta Therapeutics Phase 1/2 Duchenne muscular dystrophy micro-dystrophin gene therapy trial due to the presence of ...
FDA cautions South Koreas Ycellbio Medical Co. that it is marketing its Ycellbio kit in the U.S. without required premarket approval.
FDA cautions that no device can yet legally be considered an over-the-counter hearing aid within the definition in the FDA Reauthorization Act of 2017...