FDA Perturbed By Provention's Teplizumab Type 1 Diabetes Drug

Concerns Over Pharmacokinetics Data

 
• By Kevin Grogan

The US regulator is worried about deficiencies in the submission for Provention Bio’s high-profile therapy teplizumab for the prevention of type 1 diabetes that could significantly delay its review.

delays
Teplizumab approval pathway not so clear now • Source: Shutterstock

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