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Regulatory Review Period for Galafold

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Amicus Therapeutics Galafol...

Contradictory Info in P&G Nyquil Filing: FDA

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FDA warns Procter & Gamble (P&G) about unresolved contradictory information in the electronic listing for one of its Nyquil produc...

Incyte Accelerated Approval for Skin Cancer Drug

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FDA grants Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr) for treating adults with metastatic or recurrent l...

Steps Needed to Address Drug Shortages: Report

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The Senate Homeland Security & Governmental Affairs majority staff issues a report recommending six things FDA, Congress, and othe...

Ways to Increase Clinical Trial Diversity: PhRMA

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Pharmaceutical Research and Manufacturers of America tells the White House Office of Science and Technology Policy its three sugge...

Roche/Lilly Collaborate on Alzheimers Test

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Roche and Eli Lilly collaborate to develop Roches Elecsys Amyloid Plasma Panel, a blood test designed for making earlier diagnoses...

Biological Product Deviation Reports Up: CBER

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The CBER FY 2022 biological product deviation reporting annual summary says there was a 3% increase in reports submitted over FY 2...

Regulators Need to Keep Up with Patient Influencers: Study

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A new University of Colorado Boulder study points to the need for FDA to work harder to follow and consider further regulating soc...

Regenerons Evkeeza Expanded Use in Young Children

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FDA approves an expanded indication for Regeneron Pharmaceuticals Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering ...

Karuna Mid-Year NDA Planned for Schizophrenia Drug

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Karuna Therapeutics plans a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline resul...