January 10, 2025
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]
January 10, 2025
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]
January 10, 2025
Background The Fit-for-Purpose (FFP) Initiative provides a pathway for regulatory acceptance of dynamic tools for use in drug development programs. Due to the evolving nature of […]
January 10, 2025
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
January 10, 2025
For Immediate Release: January 10, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today the […]
January 10, 2025
TOPLINE: The presence of erosions at diagnosis, longer disease duration, and comorbidities such as fibromyalgia and obesity are associated with the development of difficult-to-treat rheumatoid arthritis […]
January 10, 2025
Researchers at the University of Oxford have reported results of a new blood test designed to detect multiple types of cancer, including in early stages. The […]
January 10, 2025
TOPLINE: According to a secondary analysis of the 24- Month Myopia Outcome Study of Atropine in Children (MOSAIC) trial, 0.05% atropine eye drops were more effective […]
January 10, 2025
Clinicians generally shouldn’t use potassium-competitive acid blockers (P-CAB) as first-line therapy for acid-related conditions, nonerosive gastroesophageal reflux disease (GERD), or peptic ulcer disease, according to a […]
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