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Milestone Misses Approval on Irregular Heart Beat NDA

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FDA sends Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to con...

Advocates Blast Hiring Quack for Autism Study

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The Autism Self-Advocacy Network sharply criticizes HHS for hiring quack David Geier to study a potential link between autism and ...

Bipartisan Patent Coordination Bill In

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A bipartisan group of five Senate Judiciary Committee members introduces legislation to establish an FDA/Patent and Trademark Offi...

FDA to Cut Another 3,500 Employees Under HHS Plan

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HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced reductions in force plan to cons...

FDA Likely to Miss Review Deadlines: Staff

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An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of...

Solenos Vykat OKd for Prader-Willi Hyperphagia

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FDA approves a Soleno Therapeutics NDA for Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in indiv...

Prometheus, Owner Paying $550,000 for False Claims

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The Department of Justice reaches a settlement in which medical device company Prometheus and its owner agree to pay $550,000 to r...

Merck Seeks Approval for Subcutaneous Keytruda

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FDA accepts a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved soli...

Fresenius Prolia, Xgeva Biosimilars Approved

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FDA approves Fresenius Kabi BLAs for biosimilar denosumab products that reference Amgens Prolia and Xgeva.

FDA Clears Vasorum Vascular Closure Device

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FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.