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2 Medical Device FAQs Issued

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FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse eve...

Celltrions Humira Biosimilar Now Interchangeable: FDA

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

Trump to FDA: Boost Generics, OTCs, Rx Imports

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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

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

Naturista Store Markets Unapproved Drug: FDA

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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...

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...