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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...

Replimune BLA Resubmission for Melanoma Therapy

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FDA accepts for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating...

Roches Giredestrant Combo Shows Positive Phase 3 Data

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Roche reports new favorable data from the Phase 3 evERA Breast Cancer study of its investigational oral therapy giredestrant, used...

Cell, Gene Therapy Monitoring Guide Encouraging: Attorneys

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Attorneys at Hyman, Phelps & McNamara say they are encouraged by an FDA draft guidance outlining a roadmap for postapproval monito...

AdvaMed Proposes MAHA Pathway for Devices

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The Advanced Medical Technology Association outlines a series of recommendations aimed at strengthening U.S. leadership in medical...

Summits Ivonescimab Outperforms Tislelizumab in Trial

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Summit Therapeutics reports that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significant...

FDA Updates Rybelsus Label for CV Risk Reduction

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FDA approves a new indication for Novo Nordisks Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovasc...