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Celcuity NDA Gets Priority Review for Breast Cancer

[ Price : $8.95]

FDA accepts for priority review a Celcuity NDA for gedatolisib in patients with hormone receptorpositive, HER2-negative, PIK3CA wi...

Objectionable Conditions in Prodrome Sciences BIMO Inspection

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FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.

Guide on Endpoints for Multiple Myeloma Accelerated Approval

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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...

Novo Nordisk Supplements Semaglutide Petition

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Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compound...

Alert Issued on Vantives Prismaflex Systems

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FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after...

Clinical Hold Lifted on GH Research Antidepressant

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FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in th...

Qualgen FDA 483 Cites Quality Issues

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FDA inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures dur...

High Court Agrees to Hear Skinny Label Dispute

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The U.S. Supreme Court agrees to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and ...

Pazdur, Others Concerned About Voucher Program Integrity

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Former FDA oncology drug leader Richard Pazdur says concerns surrounding a controversial fast-track drug review initiative under c...

Novartis Wins Breakthrough Status for Ianalumab

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FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.