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Ascendis Pharma NDA Review Extended

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FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submis...

FDA OKs Expanded Clinolipid Use

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FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in...

Respironics Recall of Trilogy Evo Ventilators

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Philips Respironics recalls (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power...

Novo Nordisk Filing BLA for Hemophilia A Drug

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Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific anti...

Merus Breakthrough Status for Petosemtamab

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FDA grants Merus a breakthrough therapy designation for petosemtamab for treating certain patients with recurrent or metastatic he...

Warning on Cue Healths Covid Tests

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FDA issues a warning for healthcare providers and consumers not to use Cue Healths Covid-19 tests due to the increased risk of fal...

Eugia Sent 7-Item 483 After India Inspection

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FDA issues Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its st...

FDA Priority Review for Dupixent sBLA

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FDA accepts for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on main...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.

FDA OKs Merck Kidney Cancer Drug

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FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...