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...
FDA cautions Silliker contract testing laboratory about CGMP violations at its Gainesville, FL, facility.
FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.
