FDA commissioner Robert Califf and three former commissioners offer their perspectives on the ways the incoming administration can succeed at FDA.
Boehringer Ingelheim reports disappointing data from its CONNEX clinical trial program evaluating iclepertin in cognitive impairment in adults with sc...
Medline Industries recalls its Medline Fluid Delivery Set with Drip Chamber because the devices were incorrectly assembled.
Citing potentially lethal risk, an FDA Early Alert says Fresenius Kabi is recommending updates to some software for its Ivenix Infusion System.
An FDA alert warns healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs and Endo USA.
Federal Register notice: FDA makes available a draft guidance entitled Recommendations To Reduce the Risk of Transfusion Transmitted Malaria.
FDA sends Atara Biotherapeutics a complete response letter on its BLA for Ebvallo (tabelecleucel), a monotherapy treatment for adult and pediatric pat...
FDA publishes a draft guidance on developing drugs to prevent and treat cancer-related chemotherapy-induced peripheral neuropathy.
