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CGMP Issues Found in PMS4PMS Inspection

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FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufact...

FDA Clears eGenesis Perfusion Trial

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FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patie...

Amlitelimab Benefit in Inflammatory Asthma: Sanofi

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Sanofi says data from a Phase 2 study of amlitelimab misses its endpoint in adults with moderate-to-severe asthma, while promising...

Mural Oncology Scraps Nemvaleukin Alfa

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Mural Oncology discontinues all clinical development of its lead drug candidate, nemvaleukin alfa based on disappointing results f...

FDA Authorizes Clicks Migraine Digital Therapeutic

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FDA grants Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, a prescription d...

TytoCare Get Clearance for AI Lung Sound Device

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FDA clears a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence-based device for detecting al...

China Stricter than U.S. in Cancer Drug Approvals: Study

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Chinese medical school researchers who analyzed cancer drug surrogate endpoint approvals in the U.S. and China say China appears t...

Address Heart Failure Patient-Reported Outcome Issues

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Researchers say some issues need to be resolved if patient-reported outcomes are to be used as a surrogate in heart failure drug a...

Recall All Humacyte Symvess Products: Petition

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Citing concerns raised by a vascular surgeon when he was a CDRH medical reviewer, Harmed Americans for Reform in Medical Device Sa...

TEST

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TEST