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CGMP Violations at Jiangsu NHWA

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FDA warns Chinas Jiangsu NHWA Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

FDA Approves 1st Modified Risk Tobacco Products

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FDA approves eight smokeless tobacco products under the new modified risk tobacco product pathway.

IntelGenx Resubmits NDA for Migraine Drug

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FDA accepts for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film f...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Jiangsu NHWA Pharmaceutical Co. and Sofie Co.

Concerns on FDA Gastroparesis Guidance

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Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.

FDA Breakthrough for Knee Biofilm Infection Killer

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FDA grants Garwood Medical a Breakthrough Device designation for its BioPrax device for eliminating biofilm infections on prosthet...

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...