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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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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.

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Amnio Technology Illegally Marketing Amniotic Products: FDA

FDA warns Phoenix, AZ-based Amnio Technology it is illegally manufacturing and distributing amniotic membrane and fluid products that have significant...

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Human Drugs

Otsuka Reports Interim Data on Sibeprenlimab

Otsuka reports positive topline interim data from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immunoglobulin A nephrop...