Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries
US FDA
Samsung Electronics Co., Ltd. announced that the sleep apnea feature[1] on the Samsung Health Monitor app[2] has received De Novo authorization from the United States Food and Drug Administration (FDA). This feature, which detects signs of sleep apnea using a compatible Samsung Galaxy Watch and Phone, was the first of its kind to be authorized […]