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Celltrions Humira Biosimilar Now Interchangeable: FDA

[ Price : $8.95]

FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

Trump to FDA: Boost Generics, OTCs, Rx Imports

[ Price : $8.95]

A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and...

Petition Seeks GMP Amendment for Sampling Logbooks

[ Price : $8.95]

A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of...

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

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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

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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

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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...