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FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse eve...[ Price : $8.95]
FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.[ Price : $8.95]
A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and...[ 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...[ Price : $8.95]
FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contai...[ Price : $8.95]
FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufact...[ Price : $8.95]
FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patie...[ Price : $8.95]
Sanofi says data from a Phase 2 study of amlitelimab misses its endpoint in adults with moderate-to-severe asthma, while promising...