FDA releases a final guidance entitled Electromagnetic Compatibility (EMC)of Medical Devices that offers the agencys current thinking on recommended i...
Federal Register notice: FDA classifies non-implanted electrical stimulation devices for management of premature ejaculation into Class 2.
India-based Lupin Pharmaceuticals hires recently retired FDA New Jersey District director Diana Amador-Toro as the companys senior vice president of g...
The U.S. Government Accountability Office writes HHS about the need for FDA to make it a high priority to act on inspection-related recommendations th...
U.S. Senators Jacky Rosen (D-NV) and Todd Young (R-IN) introduce their bipartisan Strengthening Cybersecurity for Medical Devices Act that would manda...
FDA extends the review of an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), for treating amyotrophic lateral scleros...
Centessa Pharmaceuticals discontinues its development of lixivaptan for autosomal dominant polycystic kidney disease after due to a questionable safet...
FDA says it has approved a new dermal handpiece for the Apyx Renuvion/J-Plasma.