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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.

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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.

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Human Drugs

Issues Found in BIMO Clinical Site Inspection

FDA warns Orange, CA-based neurologist Namita Goyal about violations found in a bioresearch monitoring inspection of a clinical trial she conducted.