FDA | ASweetLife

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, to improve glycemic control in adults with diabetes mellitus. Afrezza is administered at the beginning of each meal, or within 20 minutes after starting a meal.

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 human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA

FDA and Patient Live Chat: The Recap

As I mentioned earlier, today marks a huge day in the diabetes community’s collaboration with the FDA, the government agency in charge of…

Diabetes and the FDA: A First-Ever Live Chat

Ain’t no party like an FDA party. I’m being serious. This Monday, March 31st, the FDA’s Courtney Lias and StripSafely.com‘s…

FDA to Review NDA for Lixisenatide, Sanofi’s New Type 2 Diabetes Therapy

The FDA has accepted Sanofi's New Drug Application (NDA) for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes, for review. The acceptance of the lixisenatide NDA filing follows the February 1, 2013, European Commission approval of lixisenatide in the European Union.

FDA Delays Review of Novo Nordisk’s New Drug Applications for Tresiba and Ryzodeg

The U.S. FDA issued a Complete Response Letter regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) informing Novo Nordisk that an application cannot be approved in its current form.

FDA Clears Next-Generation OmniPod

Insulet Corporation, the leader in tubeless insulin pump technology, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation OmniPod® Insulin Management System.

Degludec, Novo Nordisk’s New Insulin, On Its Way To FDA Approval

The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) completed its meeting regarding the New Drug Applications (NDA) for Novo Nordisk's insulin degludec (to be marketed under the name Tresiba) and insulin degludec/insulin aspart.

FDA approves Lucentis for Diabetic Macular Edema

The U.S. FDA has approved Roche's Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes. The FDA previously had approved Lucentis to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula. Lucentis also is approved to treat macular edema following retinal vein occlusion...

First US Artificial Pancreas Outpatient Trial Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes...