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FDA Archives

FDA

Updated 4 weeks ago
Smaller, Lighter OmniPod Earns FDA Approval

The FDA recently approved the next-generation OmniPod from Insulet, giving people with insulin-dependent diabetes an even less invasive way to manage their diabetes.

Comments 0 comments - Apr 19, 2013 - * * * * *

Could Pig Worms Lead to the Cure for Type 1?

Research into a cure for type 1 diabetes proceeds on several fronts. One interesting approach is seeking ways to manipulate the autoimmune system to prevent the body's mistaken destruction of pancreatic beta cells. Another tack is the transplantation of pancreatic tissue, either from human cadavers or carefully isolated "clean" pigs that have been specially raised for the purpose. 

Comments 0 comments - Mar 7, 2013 - * * * * *

Tandem Announces Two Partnerships

Tandem Diabetes Care, Inc. has teamed with Dexcom to expand an existing partnership to include development of Dexcom’s latest continuous glucose monitoring system, the G4 Platinum. The U.S. Food and Drug Administration approved the new CGM in October.

Comments 0 comments - Feb 17, 2013 - * * * * *

Type 2: FDA OKs Canagliflozin But Has Concerns About Heart Risk

In a 10-5 vote, an FDA panel has recommended that the agency approve the marketing of Johnson & Johnson's InvokanaTM (canagliflozin), an oral once-daily drug for treating type 2 diabetes in adults.

Comments 0 comments - Feb 1, 2013 - * * * * *

Lilly Says Its New Injectible Outperforms Three Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

Comments 0 comments - Nov 20, 2012 - * * * * *

FDA Approves Dexcom’s G4

The FDA has approved U.S. sales of Dexcom's G4TM PLATINUM continuous glucose monitor. The San Diego-based manufacturer said it is taking orders and plans to begin shipping the device to patients within the next few weeks.

Comments 0 comments - Nov 16, 2012 - * * * * *

Lilly Says Its New Injectible Outperforms 3 Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

Comments 0 comments - Nov 5, 2012 - * * * * *

Oral Agents for Lowering Blood Sugar in Type 2 Diabetes

Author’s note: Throughout this series, I will inject my own opinion, which frequently differs from that of the medical establishment in this field. Having had diabetes for more than 66 years, I place my emphasis on the well-being of fellow patients.

Comments 0 comments - Oct 21, 2012 - * * * * *

Needle-Free CGM Could Be Available in 2013

Philadelphia-based Echo Therapeutics plans to introduce a needle-free continuous glucose monitoring system to the US market in 2013, pending FDA approval. The Symphony® tCGM is a two-part device that monitors blood glucose by taking readings through a user’s skin rather than via finger pricks. It is intended for use by anyone with diabetes, not just insulin pump users.

Comments 0 comments - Sep 26, 2012 - * * * * *

US Sale of Generic Actos Gets FDA Nod

The Food and Drug Administration has approved US sale of generic pioglitazone (trade name Actos) for the treatment of type 2 diabetes. Actos, originally developed and trademarked by Takeda Pharmaceuticals, works by decreasing insulin resistance in type 2 patients. The prescription drug, which belongs to the class of drugs known as thiazolidinediones (TZDs), has enjoyed great commercial success in the United States since its introduction in 1999, posting estimated sales last year of $2.7 billion.

Comments 0 comments - Aug 27, 2012 - * * * * *

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