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Vertex Cystic Fibrosis Drug Approved

[ Price : $8.95]

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

Farxiga OKd to Reduce Heart Failure Hospitalizations

[ Price : $8.95]

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...

Draft Guide on Drug Master Files

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FDA makes available a draft guidance entitled Drug Master Files.

Lawmakers Want Answers on Takeda Natpara Recall

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Several lawmakers write FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recal...

Bayer Files sNDA to Extend Mirenas Use

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Bayer submits a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrau...

FDA Clears Canons Advanced CT Image Quality

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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.

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 ...