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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...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 9/17/2021.

FDA OKs Neovasc IDE for Reducer Device Trial

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FDA approves a Neovasc IDE for its COSIRA-II IDE clinical trial that will evaluate the Reducer device and its use in treating cert...

Panel Backs Limited Covid Booster Shots

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An FDA advisory committee unanimously votes to recommend Pfizer-BioNTechs Comirnaty Covid-19 booster vaccine in individuals 65 yea...

Q & A Guide on Biosimilar Development

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Federal Register notice: FDA makes available a final guidance entitled Questions and Answers on Biosimilar Development and the BPC...

Pfizer Expands Chantix Recall to Include All Lots

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Pfizer expands its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential presence o...

FDA Safety Alert on Greenpark Compounded Drugs

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An FDA safety alert warns healthcare professionals and patients not to use compounded products from Prescription Labs, doing busin...

Consent Decree Against Florida Drug Outsourcer

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A Florida federal court enters a consent decree against Premier Pharmacy Labs that prohibits it from producing or distributing any...

FDA Clinical Hold on Protagonist Rusfertide Studies

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FDA places a clinical hold against three Protagonist Therapeutics clinical studies for rusfertide due to concerning mouse study fi...