Sanofi and MannKind Corporation have entered into a worldwide exclusive licensing agreement for development and commerci…
Afrezza
Inhaled Insulin for Diabetes: Is Afrezza Worth the Risks?
Will I prescribe Afrezza for people with diabetes? Not a lot, and not for past or present smokers, and not for people w…
FDA Approves Afrezza Rapid-Acting Inhaled Insulin
The U.S. FDA approved Mannkind Corporation's Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin, …
FDA Advisory Committee Recommends Approval of Mannkind’s Inhaled Insulin, Afrezza
The U.S. FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to recommend that Afrezza (insulin hu…
MannKind Seeks FDA Approval for Inhaled Insulin
MannKind Corporation has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking…
Positive Results for Mannkind’s Inhaled Insulin, Afrezza
MannKind Corporation has announced that it has positive preliminary results from two Phase 3 clinical studies of Afrezza…
Mannkind Confirms Studies using Afrezza Insulin Threapy
MannKind Corporation announced that it has confirmed with the U.S. Food and Drug Administration the design of two clinic…
Inhaled Insulin, Afrezza, Does Not Increase Cardiovascular Risk
Treating type 1 and type 2 diabetes with investigational ultra rapid acting mealtime insulin Afrezza (insulin human [rDN…
FDA Rejects Afrezza, Mannkind’s Inhaled Insulin
The FDA's Center for Drug Evaluation and Research has issued a complete response letter to Mannkind corp. regarding the …
FDA Informs Mannkind It Needs More Time to Review AFREZZA NDA
The FDA informed MannKind Corporation that it would not be able to complete the review of the New Drug Application (NDA)…