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FDA Alert on Baxters Infusion Pump

[ Price : $8.95]

FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.

Official Action Indicated Rare in GCP Inspections: Report

[ Price : $8.95]

FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in...

J&J Seeks Approval for Oral Peptide for Psoriasis

[ Price : $8.95]

Johnson & Johnson files an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque ...

Maquet Servo Ventilators in Class 1 Recall

[ Price : $8.95]

Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate...

Industry Vet and Academic Tidmarsh Named CDER Head

[ Price : $8.95]

FDA names Stanford pediatrics adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director.

Integra Recalls MicroMyst Applicators

[ Price : $8.95]

Integra LifeSciences recalls (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilizat...

Sarepta Disregards FDA Request to Stop Shipping Elevidys

[ Price : $8.95]

Sarepta brushes off an informal request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene t...

Roche Reports Mixed Data on COPD Studies

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Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clini...

Guide on Biosimilar Formal Meeting Requsts

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FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

SunMed Manual Resuscitators Recalled

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SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.