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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...

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Human Drugs

U.P. Oncolytics Gets Orphan Status for Glioma Therapy

FDA awards U.P. Oncolytics an orphan drug designation for its oncolytic virus-based therapy to treat malignant gliomas.