An FDA update says contrary to an earlier alert, all new neonatal incubators currently supplied in the U.S. do not show concerning levels of airborne ...
FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle ...
CDRHs annual report says it granted marketing authorization to 120 novel devices in 2024, which was four less than the previous years record-setting 1...
Federal Register notice: FDA makes available a draft guidance entitled Recommendations To Reduce the Risk of Transfusion Transmitted Malaria.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FDA publishes a draft guidance on developing drugs to prevent and treat cancer-related chemotherapy-induced peripheral neuropathy.
Federal Register notice: FDA seeks public comments on the use of cannabis-derived products (CDPs) in animals.
