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FDA Clears Canons Advanced CT Image Quality

[ Price : $8.95]

FDA clears a Canon Medical Systems 510(k) for its Advanced Intelligent Clear-IQ Engine (AiCE) for use on the Aquilion Precision CT...

Ram Pharma Gets Form-483 After Inspection

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FDA posts a Form-483 from a July inspection at Ram Pharmas Idaho Falls, ID outsourcing facility.

Vertex Cystic Fibrosis Drug Approved

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FDA approves a Vertex Pharmaceuticals NDA for Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy to...

Farxiga OKd to Reduce Heart Failure Hospitalizations

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FDA approves AstraZenecas Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in certain adults with T...

Alexion BLA Approved for Ultomiris in Rare Disease

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FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) for treating atypical hemolytic uremic syndrome to in...

Ortho Sera Extended Antigen Phenotyping Cleared

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FDA clears an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho ...

Draft Guide on Drug Master Files

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Federal Register notice: FDA makes available a draft guidance entitled Drug Master Files.

10 Info Collections Approved by OMB

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Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB.

American Gene Tech IND for HIV Gene Therapy

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American Gene Technologies files an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy be...

J&J Recalls Baby Powder Due to Asbestos

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FDA says Johnson & Johnson has recalled one lot of its Johnsons Baby Powder (Lot #22318RB) after an agency sample detected asbesto...