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Provention Bio, Inc.

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Latest From Provention Bio, Inc.

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

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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.

Approvals Companies

US FDA Advisory Committee Reboot (Part III): Asking The Right Questions

Rethinking the voting and discussion questions to advisory committees may be one way to ensure FDA gets the advice it needs.

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