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DTC Scrutiny Accelerating in 2026: Mintz

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A Mintz legal update says FDA appears to be sustaining and in some cases accelerating its scrutiny of prescription drug advertis...

Olympus Recalls High-Flow Insufflation Units

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Olympus recalls its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death.

Partial Hold on MacroGenics Gynecologic Cancer Therapy

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FDA places a partial clinical hold on a MacroGenics Phase 2 (LINNET) trial of its investigational immunotherapy lorigerlimab after...

Preemption Defense Opportunities, Pitfalls

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Attorney Grant Hollingsworth outlines Trump administration changes that could positively or negatively affect a preemption defense...

FDA Cites Data Integrity, Quality Control at Aurobindo Facility

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FDA cites significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma...

FDA Accepts Sibel Aria Cough Sensor in DDT

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FDA accepts the Sibel Aria cough sensor into its Drug Development Tool qualification program.

Genentech NDA for Breast Cancer Therapy

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FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.

Court Dismisses Suit Seeking FDA Pathway for Alzheimers

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A Maryland federal judge dismisses a physicians bid to force FDA to create a special, conditional access pathway for certain exper...

FDA Grants Priority Review to Savaras Molbreevi

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FDA accepts for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis.

CDERs Hoeg has SSRIs, mAbs in Crosshairs

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CDER acting director Tracy Beth Hoeg says the Center is preparing new safety reviews of widely used antidepressants and monoclonal...