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Aquestive Therapeutics Asks Approval Stay for Valtoco

[ Price : $8.95]

Aquestive Therapeutics asks FDA not to approve Neurelis Valtoco until the company performs additional studies like those Aquestive...

Tonix Changes Tonmya Phase 3 Study

[ Price : $8.95]

Tonix Pharmaceuticals says that after receiving input from FDA, it is changing elements of its Phase 3 study of its Tonmya PTSD tr...

Abernathy Overhauling FDA Tech Infrastructure: Politico

[ Price : $8.95]

FDA principal deputy commissioner Amy Abernathy says the agency is overhauling its technology infrastructure to be prepared to cop...

FDA Updates Essure Post-Market Activities

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FDA updates its online records on post-market activities and studies of Bayers withdrawn Essure birth control device.

Latest Federal Register Notices

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FDA Review posts the Federal Register notice for the week ending 8/1/2019.

Hep D Virus Drug Development Guide

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Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis D Virus Infection: Developing Drugs for T...

Draft Guide on Generic Drug User Fees

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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees under the Generic Drug User Fee Amendme...

Trump Taps MD Andersons Hahn as FDA Head

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President Donald Trump chooses to nominate MD Anderson chief medical officer Stephen Hahn to be FDA commissioner.

Panel to Review Correvio Atrial Fibrillation Drug

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Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Correvio...

Novartis Trial Misses Superiority in Cosentyx Trial

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Novartis says its EXCEED head-to-head trial comparing Cosentyx (secukinumab) to AbbVies Humira (adalimumab) in patients with activ...