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CGMP Violations at Glenmark Unit

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FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing fa...

FDA Rejects Replimune BLA for Melanoma Therapy

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FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).

FDA Wins as Sarepta Folds and Stops Shipping Elevidys

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FDA wins the latest round in its regulatory battle against gene therapy maker Sarepta Therapeutics after the company agrees to sto...

Lax GLP-1 Compounding Regulation Hurts Patients: Report

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Center for Medicine in the Public Interest president Peter Pitts says FDA must protect patients by tightening its regulation of co...

Laura Loomer Urges Ouster of CBER Head Prasad

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Conspiracy theorist and Trump confidant Laura Loomer urges the firing of CBER director Vinay Prasad due to his previous anti-Trump...

Maquet Servo Ventilators in Class 1 Recall

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Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate...

Industry Vet and Academic Tidmarsh Named CDER Head

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FDA names Stanford pediatrics adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director.

Integra Recalls MicroMyst Applicators

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Integra LifeSciences recalls (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilizat...

Sarepta Disregards FDA Request to Stop Shipping Elevidys

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Sarepta brushes off an informal request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene t...

Roche Reports Mixed Data on COPD Studies

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Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clini...