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Vaccine Panel to Discuss RSV Pediatric Vaccine

[ Price : $8.95]

Federal Register notice: FDA announces a 12/12 Vaccines and Related Biological Products Advisory Committee meeting to discuss cons...

Pinnacle Making Illegal Amniotic Products: FDA

[ Price : $8.95]

FDA warns Phoenix, AZ-based Pinnacle Transplant Technologies that it is illegally manufacturing and marketing amniotic products th...

Add Semaglutide to DDC Lists: Novo Nordisk

[ Price : $8.95]

Novo Nordisk asks FDA to add its semaglutide products to the lists of drugs that should not be compounded.

FDA Approves Expanded Abrysvo Indication

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

CA Man Pleads Guilty to Selling Unapproved Drugs

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

U.P. Oncolytics Gets Orphan Status for Glioma Therapy

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

Issues Found in BIMO Clinical Site Inspection

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

Amnio Technology Illegally Marketing Amniotic Products: FDA

[ Price : $8.95]

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

Otsuka Reports Interim Data on Sibeprenlimab

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

Acromegaly NDA Hit with Complete Response Letter

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FDA sends Camurus a complete response letter on its NDA for CAM2029 (octreotide) extended-release injection and its use in treatin...