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Draeger Recalls Ventilator Breathing Filters

[ Price : $8.95]

Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.

Elsa Hallucinations Not A Surprise: AI Expert

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AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning ...

Brinsupri Approved for Non-Cystic Fibrosis Bronchiectasis

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FDA approves an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis in pa...

Keytruda/Padcev Study in Bladder Cancer Positive: Merck

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Merck announces that the combination of Keytruda (pembrolizumab) and Pfizers Padcev (enfortumab vedotin-ejfv), given before and af...

Get Strategic Intelligence from Device Warnings

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A MedDevice Online column says manufacturers can often avoid an FDA Warning Letter by providing an urgent and accountable full res...

FDA May Nix Pfizer EUA for Covid Jab in Young Kids

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The Guardian reports that the emergency use authorization for Pfizers Covid-19 vaccine for children under five may not be renewed ...

Hes Back: Makary Rehires Prasad as CBER Head

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Vinay Prasad returns as CBER head at FDA commissioner Marty Makarys request after gaining White House approval.

Novartis to Seek Approval for Sjgrens Disease Drug

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Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase ...

GSK sNDA for Oral Gonorrhoea Treatmemt

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FDA accepts for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoe...