FDA classifies as Class 1 a recall by Medtronics Covidien unit of its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly err...
The New Jersey federal court enters a consent decree of permanent injunction against Natural Solutions Foundation and its principals to stop them from...
FDA approves Coherus BioSciences Yusimry, the seventh biosimilar form of AbbVies Humira approved by the agency.
FDA tentatively approves Amphastars vasopressin injection, a generic form of Pars Vasostrict.
FDA sets a 6/22 PDUFA action date for an Amylyx NDA for its Alzheimers investigational drug.
FDA clears Bioventus neXus bone scalpel handpiece.
FDA issues a guidance with recommendations on non-clinical and clinical studies for medical devices to treat benign prostatic hyperplasia.
FDA approves fast track designation for an acute myeloid leukemia indication for Celularitys CYNK-001 cell therapy.