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Hologic BioZorb Marker Recall Class 1: FDA

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FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.

UCB Minzasolmin Parkinsons Study Misses Endpoints

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UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, af...

FDA Alert on Baxter Solution Sets

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FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled w...

Temple Retires; Bumpus Leaves FDA

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CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agenc...

Xbrane Refiles Lucentis Biosimilar BLA

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Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degenerati...

Alert on AquaFlexFlow Blood Circuits

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FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weigh...

Senators Introduce Skinny Label Generic Drug Bill

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Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labe...

Multiple Violations in BD Inspection

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FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management S...

Sombra Cosmetics CGMP Violations

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FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.

FDA OKs Mesoblasts Ryoncil Cell Therapy

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FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.