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OTC Shampoo Suit Preempted by FDA Monograph

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Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state cl...

Janssen Vaccines FDA-483

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FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, ...

Detailed Comments on Protocol Deviations Draft Guide

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Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.

Precigen BLA for Respiratory Papillomatosis Therapy

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FDA accepts for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy f...

Entrada Clinical Hold Lifted on Duchenne Drug

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FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided aut...

Ex-CDER Head Cavazzoni Rejoins Pfizer

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Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.

Medtronics Brain Stimulator for Parkinsons Approved

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FDA approves a Medtronic PMA for its BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier for use in Par...

FDA Trying to Rehire 300 Staff Recently Fired

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FDA moves over the weekend to rehire up to 300 scientists and reviewers who were terminated last week as part of the Trump Adminis...

No Panel Meeting for Brensocatib NDA

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FDA tells Insmed that it does not currently plan to hold an advisory committee meeting to discuss the companys NDA for brensocatib...

BMS Files sBLA for Opdivo+Yervoy in Colon Cancer

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) for a firs...