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New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation

View details about the NDRP Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for comments

FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing

FDA is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) that aims to…

FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

On October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq,…

Kuka Flex Forte contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Kuka Flex Forte, a product promoted and…

Metabolic Identification Based on Proposed Mass Fragmentation Pathways of the Anabolic Steroid Bolasterone by Gas Chromatography Tandem Mass Spectrometry

The metabolism of bolasterone in liver microsomes and in urine samples of rats orally treated was evaluated due to no…

Optimization of Parallel Artificial Liquid Membrane Extraction for the Determination of Over 50 Psychoactive Substances in Oral Fluid Through UHPLC–MS/MS

This study is related to the development of a microextraction method for the determination of 56 psychoactive substances in oral…

Endogenous Nature of Hydrocortisone Acetate in Horse

A proof-of-concept study to evaluate the possible endogenous nature of hydrocortisone acetate in horses by in vitro incubation experiments using homogenized…

Sports Supplement Analysis Survey for the Prevalence of WADA Prohibited Substances in the Australian Online Marketplace

A survey of 200 sports supplements purchased online in Australia and analysed for WADA Prohibited Substances. Athlete education regarding the…

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