Tag: Afrezza

MannKind Corporation representatives at the 10th annual meeting of the Diabetes Technology Society unveiled new data on its drug delivery, device and particle technologies demonstrating the bioequivalence, ease of use and efficiency of the company's novel platform. The company presented four studies evaluating...

MannKind Corporation announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind's resubmission of its New Drug Application (NDA) for AFREZZA(TM) (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding...

MannKind announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin (also combined with basal insulin), in reducing HbA1c levels in subjects with inadequately controlled type 1 diabetes...

MannKind Corp. announced the results of a two year study comparing the efficacy and safety of AFREZZA (insulin human [rDNA origin]) versus usual diabetes care. The study followed patients for a total of up to two years. The patients were randomly assigned to a treatment regimen of either AFREZZA plus...

MannKind Corporation announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA(TM) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes...