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BIO September Congressional Priorities

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The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA ...

Multiple GLP Violations at Chinas Jiangsu Kerbio

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FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical ...

FDA Breakthrough Status for Lupis Blood Purifier

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FDA grants Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, t...

Inovio Begins Rolling BLA for Rare Throat Disorder

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Inovio Pharmaceuticals begins a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papill...

Breakthrough Status for Quests Haystack MRD Test

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FDA grants Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minim...

Alert on Hyperbaric Oxygen Devices

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FDA alerts health care providers and facilities about the safe use of hyperbaric oxygen therapy devices following reports of serio...

FDA Broadens Use of Amgens Repatha

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FDA expands the approved use of Amgens cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major...

Argenx Plans sBLA for Vyvgart in Myasthenia Gravis

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Argenx says it will seek expanded approval for Vyvgart (efgartigimod alfa-fcab) to include adults with acetylcholine receptor anti...

Chikungunya Vaccine Suspended Due to Safety Concerns

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CBER suspends Valneva Austrias BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine.

FDA Study: CBD Linked to Elevated Liver Enzymes

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An FDA clinical trial finds that daily use of cannabidiol at levels typically used by consumers can cause elevated liver enzymes i...