FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to manage diabetes.
Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive sleep apnea into Cl...
CDER and CBER seek input to help advance the agencys model-informed drug development program.
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently circulating variants...
FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to include preventing mp...
CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell therapy for use in ...
Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.
Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer reporting of certai...
