FDA issues Complete Response Letter to Eli Lilly and Boehringer for empagliflozin to treat type 1 diabetes.
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Provention Bio, Inc. announced that the Company received a notification from the FDA stating that, as part of its ongoing review of the Company's Biologic License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
Insulet Corporation (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced positive results from the first pivotal trial for the Omnipod 5 Automated Insulin Delivery System. Omnipod 5, the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range and reduced HbA1c in children, adolescents, and adults, aged 6-70 years, with type 1 diabetes.
Zealand Pharma announced that the FDA has accepted for filing the company’s New Drug Application (NDA) for the HypoPal Rescue Pen (dasiglucagon) for the treatment of hypoglycemia in people with diabetes.