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Provention Bio, Inc.

http://www.proventionbio.com

Latest From Provention Bio, Inc.

Provention Maps Possible Regulatory Path For Troubled Teplizumab

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.

Companies Regulation

Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

FDA’s Mismanaged Aduhelm Review: What Went Wrong

Two House committees have launched investigations into the US FDA approval of Biogen/Eisai’s Aduhelm for Alzheimer’s, assuring that headlines questioning the effectiveness of the therapy will continue. It didn’t have to be this way.

Advisory Committees Drug Review

10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

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