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Marinus Pharma Wins Priority Review Voucher

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Federal Register notice: FDA issues a priority review voucher to Marinus Pharmaceuticals for gaining approval of a rare pediatric ...

Notice on Makena Hearing Corrected

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Federal Register notice: FDA corrects an 8/17 notice on a 10/17-19 hearing request to review and vote on whether agency approval f...

Alvotech Inspection Findings Hold Up Humira Biosimilar

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FDA sends Alvotech a complete response letter on its proposed Humira biosimilar AVT02, citing inspection deficiencies at its Reykj...

FDA Denies Most of Salix Xifaxin Petition

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FDA denies most requests in a Salix Pharmaceuticals petition asking for restrictions on approval of ANDAs citing its Xifaxin as th...

Bayer Paying $40 Million to Settle 2 Whistleblower Suits

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Bayer agrees to pay $40 million to the federal government and 20 states to resolve two whistleblower False Claims Act suits over t...

Advancing Regulatory Science at FDA 2022 Report

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FDA releases its 2022 report on advancing regulatory science with updates to the focus areas identified in the 2021 regulatory sci...

Bausch & Lomb/Novaliq NDA for Dry Eye Disease

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FDA accepts for review a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the sign...

Magnus Medical Neurostimulation for Depression Cleared

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FDA clears a Magnus Medical 510(k) for the Saint Neuromodulation System for treating major depressive disorder in adults who have ...

FDA Approves Fresenius Kabi Biosimilar

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FDA approves Fresenius Kabis Stimufend biosimilar for Amgens Neulasta.

Data Not Conclusive on Amylyx ALS Drug: FDA

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FDA reviewers dismiss new analyses and data from Amylyx that were intended to provide confirmatory evidence to support approval of...