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AI in Regulatory Science: Conference Report

[ Price : $8.95]

A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligenc...

Digital Health Technologies an FDA Priority: Article

[ Price : $8.95]

Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.

Inspections Will Suffer Under FDA Cuts: Lawyers

[ Price : $8.95]

Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity coul...

Naturista Store Markets Unapproved Drug: FDA

[ Price : $8.95]

FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contai...

CGMP Issues Found in PMS4PMS Inspection

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Authorizes Clicks Migraine Digital Therapeutic

[ Price : $8.95]

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

[ Price : $8.95]

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