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FDA Still Finding Issues at Nephron Pharmaceuticals

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A South Carolina newspaper reports that the latest FDA inspection at Nephron Pharmaceuticals found the company still has significa...

Moderna Quits CMV Vaccine After Phase 3 Failure

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Moderna stops the development of its congenital cytomegalovirus vaccine after it failed to meet the primary endpoint in a large Ph...

3rd Patient-Focused Drug Development Guidance

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FDA publishes the third in a series of guidances on aspects of collecting patient experience data to be used in medical product de...

sBLA for PadcevKeytruda Combo in Bladder Cancer

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FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...

Fast Track for Myosin Glioblastoma Drug

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FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.

QS, MDR, UDI Issues in Levo AG Inspection

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FDA warns Switzerlands Levo AG about Quality System, Medical Device Reporting, and Unique Device Identifier violations in its prod...

Repeat CGMP Violations at Guangxi Yulin

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A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found r...

FDA Orphan Status for Netherton Syndrome Drug

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FDA grants Quoin Pharmaceuticals an orphan drug designation for QRX003 and its use in treating Netherton syndrome.

Genentechs Gazyva Approved for Lupus Nephritis

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FDA approves Genentechs Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard t...

Major Staff Losses at CDER and CBER Amid Shake-up

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FDA releases hiring data showing steep declines in staffing at CDER and CBER.