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 chemicals and therefore do not need to be run for a week before clinical use.”
FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma.
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 chemicals and therefore do not need to be run for a week before clinical use.”
FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma.
CDRH’s annual report says it granted marketing authorization to 120 novel devices in 2024, which was four less than the previous year’s record-setting 124 devices.
Federal Register notice: FDA amends its regulations to reflect recent application-related actions for new animal drug applications and abbreviated new animal drug applications.
