The FDA has accepted for review the sBLA for Afrezza (insulin human) inhalation powder in children and adolescents with type 1 or 2 diabetes.
MannKind (Nasdaq:MNKD) announced today that the FDA accepted a supplemental biologics license for its Afrezza inhaled insulin ...
MannKind (MNKD) announced that the U.S. Food and Drug Administration, FDA, has accepted the supplemental biologics license application, sBLA, ...
Ritedose Pharmaceuticals, a division of The Ritedose Corporation, has secured Food and Drug Administration approval for formoterol fumarate inhalation solution (20 mcg/2 ml). “The approval further ...
The acceptance comes after a study done by the American Diabetes Association in June found that inhaled insulin is safe and ...
If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy sBLA submission based on ...