FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.
Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results that did not meet prima...
FDA says the Draeger recall correction of its Atlan A350 and A350XL anesthesia workstations is Class 1.
Smiths Medical recalls (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potential battery malfunctio...
Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness reasons.
FDA publishes a guidance with information on third-party review of 510(k)s and emergency use authorizations.
New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisements major statement is presented in a clear, conspi...
Republican Sen. Ron Johnson orders FDA, HHS, and CDC to preserve all records relating to Covid-19 vaccines, saying they will be subpoenaed if they are...
