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Phathom Gets 2 Complete Response Letters Over Impurity

[ Price : $8.95]

FDA issues two complete response letters to Phathom Pharmaceuticals one for an NDA for vonoprazan for treating erosive esophagiti...

FDA to Explain Post-Health Emergency Effects

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Ropes & Gray attorneys explain the impact of the upcoming termination of the Covid-19 public health emergency on FDA guidances and...

GE Nuclear Medicine System Recall is Class 1

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FDA says the GE Healthcare 12/19/22 recall of nuclear medicine systems is Class 1.

Eiger Wont Seek EUA for Interferon Covid Treatment: Bloomberg

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Bloomberg reports that experts are debating the value of therapeutics like Eigers lambda peginterferon against Covid.

Eylea Approved for Infants with Retinopathy

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FDA approves Regeneron Pharmaceuticals Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity.

FDA Updates Philips MDRs; 82 Deaths in 2 Months

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FDA updates an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide infor...

FDA Denies DuraSeal Spinal Sealant Petition

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FDA denies all requests in a 2013 petition seeking action against DuraSeals Spinal Sealant.

DoJ Wants Conspiracy Charge Against KVK-Tech

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Courthouse News Service says the Justice Department has asked the 3rd Circuit Court of Appeals to reinstate conspiracy charges aga...

FDA Revises Guidance on Compounding Ibuprofen

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FDA revises its guidance on compounding certain ibuprofen oral suspension products to address ongoing product shortages.

Regulatory Review Periods for Erleada and Xospata

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Federal Register notice: FDA determines for patent term extension purposes the regulatory review periods for two drug products Ja...