The FDA has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults submitted by Bristol-Myers Squibb Company and AstraZeneca… Read more
The U.S. Food and Drug Administration (FDA) issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. This step comes after a large campaign led by the Juvenile Diabetes research Foundation … Read more
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
The U.S. Food and Drug Administration (FDA) has granted Tandem Diabetes Care clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative… Read more
The U.S. Food and Drug Administration (FDA) has given Medtronic approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE (Automation to Simulate Pancreatic InsulinREsponse) study of the MiniMed Paradigm® System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for type 1 diabetes management… Read more
The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly’s type 2 diabetes drug, Byetta (exenatide) injection. Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes… Read more
ALR Technologies Inc received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Health-e-Connect (HeC) System for remote monitoring of patients in support of effective diabetes management programs. The 510(k) clearance enables the company to commence with the United States marketing and sales launch of its HeC platform… Read more
Novo Nordisk filed two new drug applications for the approval of ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart (DegludecPlus)
by the U.S. Food and Drug Administration. These new insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes. Read more
MannKind Corporation announced that it has confirmed with the U.S. Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler… Read more
Takeda has resubmitted two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) for alogliptin and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone, approved in 1999, for the treatment of type 2 diabetes, in a single tablet… Read more
