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Bausch Recalls Intraocular Lenses After Reports

[ Price : $8.95]

Bausch + Lomb recalls its enVista intraocular lenses after the company received reports of complications, which it says could not ...

Laboratory-Developed Test Decision Reviewed

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Six Sidley attorneys raise several practical questions arising from a Texas federal court decision finding that FDA does not have ...

User Fee Programs are in Jeopardy: FDA Watchers

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FDA regulatory experts warn that the agencys user fee programs could be in jeopardy based on sweeping layoffs and political indiff...

Restrict 2 Opioid Indications: Petition

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Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use di...

Rhythm Pharma Positive Data on Obesity Drug

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Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for tr...

Teva Files sBLA to Expand Migraine Therapys Use

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FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include p...

Device Reviews Will Now Take Longer: Shuren

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Former CDRH director Jeff Shuren says recent staff cuts at CDRH will likely lead to longer review times.

Allogene Gets 3 Fast Tracks for Cell Therapy

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FDA grants Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic...

Kennedy Senate Hearing Postponed

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A Senate HELP Committee postpones a hearing tentatively planned for 4/10 because HHS secretary Robert F. Kennedy, Jr. reportedly c...

Amgens Uplizna OKd for Immunoglobulin G4 Disease

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FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related d...