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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.

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Biologics

FDA Approves Expanded Abrysvo Indication

FDA approves an expanded indication for Pfizers Abrysvo RSV vaccine to include adults from age 18 and up.

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Human Drugs

CA Man Pleads Guilty to Selling Unapproved Drugs

A California man operating a company called Warrior Labz SARMs pleads guilty to selling unapproved drugs after receiving an FDA Warning Letter advisin...