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. Read more

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. Read more

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. Read more

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… Read more

FDA Clears Roche’s Accu-Chek Combo System

Roche announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Accu-Chek Combo system for insulin pump therapy. The Accu-Chek Combo system seamlessly combines a blood glucose meter with an insulin pump, which are able to exchange data in both directions via Bluetooth wireless technology. Read more

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… Read more

FDA Approves Merck’s New Type 2 Diabetes Drug Janumet

The FDA has approved Merck’s (MSD) new type 2 diabetes medication, JANUMET(R) XR (sitagliptin and metformin hydrochloride (HCl) extended-release) The new treatment combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin… Read more

FDA Clears PositiveID’s iglucose, A Wireless Communication Diabetes Management System

The U.S. Food and Drug Administration (FDA) granted PositiveID Corporation clearance for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals… Read more

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