Provention Maps Possible Regulatory Path For Troubled Teplizumab
Biotech Aims To Get Type A Meeting With FDA In Q4
Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.
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Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Advisory committee to consider whether two-year delay is clinically meaningful and substantial evidence standard is satisfied; notably, panel input is not requested on an issue that has tripped up BLA review - bridging data that suggest pharmacokinetic differences between the clinical trial and commercial drug products.