FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse events.
FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.
A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and OTC drugs and to ma...
A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of separate sampling l...
FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contains undeclared active...
FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufactured with CGMP viola...
FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patients with acute-on-ch...
Sanofi says data from a Phase 2 study of amlitelimab misses its endpoint in adults with moderate-to-severe asthma, while promising data were seen in h...
