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FDA Clears Trial Restart of Recurring Stroke Device

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FDA clears restart of a pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for clo...

Boehringers Jascayd OKd for Pulmonary Fibrosis

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FDA approves a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis.

Statistical Analysis of FDA Warning Letters

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A Hyman, Phelps & McNamara statistical analysis of FDA Warning Letters published by FDLI shows that nearly three-quarters of Warni...

FDA Warns Technological Medical

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FDA warns West Palm Beach, FL-based Technological Medical Advancement about Quality System violations in its production of two una...

Multiple Creative Essences Violations

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FDA warns Santa Fe Springs, CA-based Creative Essences about CGMP violations in its production of misbranded unapproved drugs.

FDA Outlines Quicker Path for Lexeo Gene Therapy

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FDA input offers Lexeo Therapeutics a potential accelerated approval pathway for its investigational gene therapy LX2006.

Former CBER Head Marks Joins Eli Lilly

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After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing mo...

Clinical Hold Lifted on Neurizon ALS Drug

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FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.

Priority Review for Orca Blood Cancer Cell Therapy

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FDA accepts for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with c...

FDA Authorizes Cryoablation for Low-Risk Breast Cancer

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FDA grants IceCure Medicals de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-ris...