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Change FDA AI Policies: Gottlieb

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Former FDA commissioner Scott Gottlieb says the agency should revert to clinical decision support system regulatory policies appro...

CA Man Sentenced Over Unapproved Drugs

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FDA says Jeremy Brown of Simi Valley, CA has been sentenced for introducing unapproved drugs into interstate commerce.

Sentec/Percussionaire Breathing Circuit Recalled

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Sentec/Percussionaire recalls its Phasitron breathing circuit kits after receiving a complaint that the venturi component of the k...

Pliant Pauses Bexotegrast Trial for Safety Review

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Pliant Therapeutics pauses enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of ...

Guide on IRB Written Procedures

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FDA posts a final guidance entitled Institutional Review Board (IRB) Written Procedures that is intended to harmonize FDA and HHS ...

Boehringer Ingelheim Plans NDA for Lung Disease

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Boehringer Ingelheim plans to submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following its release of...

AI Prostate Cancer Detector Cleared by FDA

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FDA clears an Ibex Medical Analytics 510(k) for the Ibex Prostate Detect, an in vitro diagnostic that uses artificial intelligence...

Tempest Gets Fast Track for Amezalpat

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FDA grants Tempest Therapeutics a fast track designation for amezalpat (TPST-1120) for treating patients with hepatocellular carci...

Roche Shares Positive Data on Gazyva

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Roche shares with FDA positive data from the Phase 3 REGENCY trial of Gazyva (obinutuzumab) in people with active lupus nephritis.

Lawmakers Urge FDA to Block Super Bowl Drug Ad

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Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) call on FDA to take enforcement action against a planned direct-to-consumer ...