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J&J Touts Vaccine Booster Data

[ Price : $8.95]

Johnson & Johnson reports new data showing increased protection against Covid-19 when a booster shot of its vaccine is administere...

Fibromyalgia Treatment Group Selling Unapproved New Drugs: FDA

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FDA warns the Fibromyalgia Treatment Group it is selling unapproved new drugs.

First Lucentis Biosimilar Approved by FDA

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FDA approves a Samsung Bioepis and Biogen BLA for Byooviz (ranibizumab-nuna), the first biosimilar version of Genentechs age-relat...

OTC Monograph FDA Portal

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Federal Register notice: FDA makes available on its Web site certain final administrative orders, including for over-the-counter (...

False Positives With Abbott Covid Test: FDA

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FDA issues an alert about the potential for false positive results with Abbott Moleculars Alinity m SARS-CoV-2 AMP Kit and Alinity...

AbbVie sBLA for Skyrizi in Crohns Disease

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AbbVie files a BLA supplement for Skyrizi (risankizumab-rzaa) for treating patients 16 years and older with moderate to severe Cro...

Guide on Controlled Correspondence Related to Quality

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FDA posts a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence for generic drug developers...

Medtronic Unit Recalls Brain Aneurysm Stents

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Medtronics Micro Therapeutics unit recalls its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield...

Pfizer Touts Favorable Covid Jab Data in Children

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Pfizer and BioNTech announce results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody re...

FDA Complete Response on Verrica NDA

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FDA sends Verrica Pharmaceuticals a complete response letter on its NDA for VP-102 for treating the skin disease molluscum contagi...