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HHS Roadmap Outlines FDA Flexibilities Post-Covid

An HHS Covid-19 Public Health Emergency Transition Roadmap outlines FDAs flexibilities and actions that will not be affected after the health emergenc...

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Human Drugs

Phathom Gets 2 Complete Response Letters Over Impurity

FDA issues two complete response letters to Phathom Pharmaceuticals one for an NDA for vonoprazan for treating erosive esophagitis, and the other for...

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FDA to Explain Post-Health Emergency Effects

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

Medical Devices

GE Nuclear Medicine System Recall is Class 1

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

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Human Drugs

Eiger Wont Seek EUA for Interferon Covid Treatment: Bloomberg

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

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Human Drugs

Eylea Approved for Infants with Retinopathy

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

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Medical Devices

FDA Updates Philips MDRs; 82 Deaths in 2 Months

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

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Medical Devices

FDA Denies DuraSeal Spinal Sealant Petition

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

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Human Drugs

DoJ Wants Conspiracy Charge Against KVK-Tech

Courthouse News Service says the Justice Department has asked the 3rd Circuit Court of Appeals to reinstate conspiracy charges against KVK-Tech, a New...

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Human Drugs

FDA Revises Guidance on Compounding Ibuprofen

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