This is my first look at Provention Bio (), another biotech that is in near term PDUFA limbo with its lead therapy teplizumab (PRV-031).In this article I review its prospects for FDA approval ...

This week, the FDA approved a new treatment called teplizumab that delays the onset of type 1 diabetes. TZIELD, the brand name, will total $193,000 over the 14-day treatment.

In the PROTECT trial, children ages 8-17 years were randomized within six weeks of their type 1 diagnosis to receive teplizumab or placebo. The treatment, intravenous teplizumab, was given for 12 days ...

Clarivate’s “Drugs to Watch” list for 2023 mentions 15 therapeutics, including teplizumab for type 1 diabetes (T1D). News. All News Press Releases Product Approvals and Launches.

The FDA Thursday approved teplizumab, the first drug to delay the onset of type 1 diabetes (T1D). Teplizumab, a biologic, will be sold under the brand name Tzield and is given through intravenous ...

--Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced extended follow-up data showing a single 14- day course of ...

MacroGenics and Eli Lilly announced that they achieved their targeted patient enrollment for their Phase 2/3 PROTEGE trial evaluating teplizumab for the treatment of recent-onset type 1 diabetes.

Similar to findings in previous trials of teplizumab in patients with new-onset type 1 diabetes, the lymphocyte count decreased to a nadir on day 5 (total decrease, 72.3%; interquartile range, 82. ...