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FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head…

FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER…

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements

GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle.…

Newly Added Guidance Documents

Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.

Mercaptans in malodorants break disulfide bridges in human serum albumin and form adducts suitable as biomarkers of exposure in vitro

Disulfide adducts of mercaptans with cysteine residues in human serum albumin were detected as tripeptides and dipeptides after proteolysis with…

Development and validation of general plasma screening method for performance enhancing drugs in racehorses utilizing liquid chromatography–high‐resolution mass spectrometry (LC–HRMS)

In this manuscript, a high-throughput automated assay based on liquid chromatography-high-resolution mass spectrometry (LC-HRMS) suitable for use as an initial…

Changing trends in anabolic‐androgenic steroid use within Scottish prisons: Detection, prevalence, and quantitation

This study reports the qualitative and quantitative detection of anabolic-androgenic steroids (AASs) in seized samples from prisons. Since 2022 there…

In vivo comparative study of hemp straw exposure and cannabidiol oil administration in horse urine

The goals of this study were, first, to provide recommendations on the use of hemp straw before horse competitions and,…

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