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Biologics

Intellia Reports Positive Data on Gene Therapy

Intellia Therapeutics reports positive data from the ongoing Phase 1/2 study of NTLA-2002, a CRISPR-based gene editing therapy, in patients with hered...

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Human Drugs

Probe Leqembi, Kisunla Trials: Public Citizen

The Public Citizen Health Research Group calls for a federal investigation into clinical trials for two Alzheimers drugs that may have violated inform...

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Pfizer submits pages of recommended changes to an FDA draft guidance on incorporating voluntary patient preference information over a medical devices ...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

FDA to Study Adherence and Patient Preference in Ads

FDA says the CDER Office of Prescription Drug Promotion will research how consumers and primary care physicians respond to drug ads containing informa...

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AI Forcing FDA to Rethink Everything: Califf

FDA commissioner Robert Califf says the agency is being forced by artificial intelligence to rethink how it conducts business.