FDA Issues Complete Response Letter for Type 2 Diabetes Drug Empagliflozin

Lilly - Boehringer - logo

The FDA has issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.
The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. Read more

Medtronic Launches the i-port Advance, An All-in-One Injection Port and Inserter

Medronic - iport Advance

Medtronic has begun distribution of i-port Advance, the first device to combine an injection port and an inserter in one complete set. i-port Advance can be used for people on insulin injection therapy who want to administer insulin conveniently while eliminating the need to puncture the skin with each dose of medication. i-port Advance injection port is FDA approved… Read more

FDA Grants Orphan Drug Status to DiaVacs’s Type 1 Diabetes Reversal Drug

DiaVacs

The FDA has granted orphan drug designation for the DiaVacs’s type 1 diabetes therapy, DV-0100. The therapy halt’s the body’s autoimmune reaction against the pancreatic islet cells which are responsible for producing insulin, thus allowing them to produce insulin normally and reversing the trajectory of the disease. Read more

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