Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the Cue Covid19 Test, and Cue Covid19 Home/OTC Test.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug sponsors.
FDA announces approved labeling changes for Sandoz fludarabine phosphate injection under the Oncology Center of Excellences Project Renewal.
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 warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.
FDA warns Italys Originitalia about CGMP violations in its production of finished drugs.
Novo Nordisk petitions FDA to take specific steps to follow through on the companys nomination of semaglutide (Rybelsus, Ozempic, Wegovy) to the lists...
