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Medical Devices

Baxter Class 1 Recall of Life2000 Ventilator

Baxter Healthcare recalls (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail to issue a low gas p...

Medical Devices

Pfizers Changes to Total Lifecycle Patient Preference Guide

Pfizer submits pages of recommended changes to an FDA draft guidance on incorporating voluntary patient preference information over a medical devices ...

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Human Drugs

Researchers Find Alzheimers Potential in Semaglutide

Researchers from Case Western Reserve University School of Medicine report that semaglutide may reduce the risk of Alzheimer's disease in people with ...

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Human Drugs

ASHP Sees 277 Active Drug Shortages

The American Society of Health-System Pharmacists says there were 277 drug shortages as of September, down from an all-time high of 323.

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FDA General

Safety Alert on Regener-Eyes Eye Drops

An FDA safety alert warns about Regener-Eyes manufactured by Regenerative Processing Plant because the eye drops likely contain amniotic fluid.

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Human Drugs

Priority Review for Glioma Imaging Agent

FDA accepts for priority review a Telix NDA for Pixclara (18F-floretyrosine), a positron emission tomography agent for glioma imaging.

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Human Drugs

Alto Neuro Depression Study Fails

Alto Neuroscience says a study of its major depressive disorder investigational drug did not meet its primary endpoint.

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Federal Register

Vaccine Panel to Discuss RSV Pediatric Vaccine

Federal Register notice: FDA announces a 12/12 Vaccines and Related Biological Products Advisory Committee meeting to discuss considerations for pedia...

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Biologics

Pinnacle Making Illegal Amniotic Products: FDA

FDA warns Phoenix, AZ-based Pinnacle Transplant Technologies that it is illegally manufacturing and marketing amniotic products that have CGMP deviati...

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Human Drugs

Add Semaglutide to DDC Lists: Novo Nordisk

Novo Nordisk asks FDA to add its semaglutide products to the lists of drugs that should not be compounded.