The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
MAY 29 2026
APPROVED · 5 DAYS AGO

MannKind Corporation Afrezza (insulin human (inhalation powder)) $MNKD

for diabetes mellitus in children and adolescents aged 6 and older

sNDA

FDA approved expanded labelling for Afrezza (inhaled insulin) to include children and adolescents aged 6 and older with diabetes. Afrezza becomes the first and only inhaled mealtime insulin approved for this pediatric population, offering a needle-free option alongside existing injection and pump regimens.