San Diego — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritis and inflammation, continues to show good efficacy […]
To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER is disclosing information from our scientific review […]
Based on a synthesis of best available evidence, the American Gastroenterological Association (AGA) has released clinical recommendations on fecal microbiota-based therapies (FMT) in adults with gastrointestinal […]
Docket Number: FDA-2014-D-1167 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
TOPLINE: Repeat, within-episode antibiotic treatment (often in the same class) for respiratory tract infections (RTIs) in adults and children accounts for ≥ 10% of overall antibiotic […]
FDA works to ensure the medications that are available to hospitals, health systems and patients are safe, effective and of high quality. For application products, typically […]
[03/15/2024] Today, FDA is announcing a new webpage to showcase how the agency uses one of its oversight tools, inspections, to help ensure drug safety and […]
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