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.
Novavax expects to apply this month for an FDA EUA for its Covid-19 two-dose vaccine.
FDA warns Carson City, NV-based Alpha Aesthetics about Quality System and Medical Device Reporting violations in its manufacturing of silicone facial ...
FDA issues a guidance with recommendations for remotely using digital health technologies in clinical investigations.
University of Minnesota researchers ask FDA to approve an EUA for the generic antidepressant fluvoxamine as a Covid-19 treatment.
FDA places a clinical hold on 10 Gilead trials of an investigational HIV drug.