A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...
Near-instantaneous, quality-reviewed case availability would shift signal detection from periodic retrospection to continuous ...
Eli Lilly was attracted by a deliberately cultivated life sciences strategy anchored in a region where manufacturing ...
Oncology remains the leading M&A magnet, with ASCO data catalyzing interest in new combinations and next-generation modalities across major pharma buyers. GLP-1 deal interest is broadening beyond ...
At CPHI Americas 2026, PharmTech spoke with Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, and ...
Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems. Rare medical conditions can do more than ...
According to the USP report, the duration of drug shortages increased to 5.3 years in 2025. This is a result of new shortages ...
The US Pharmacopeia’s 2025 annual drug shortages report found that while the total number of shortages declined by 23% in ...
Clinical data warehouses maximize veracity via schema-on-write and ACID guarantees, but ETL rework, limited modality support, ...
CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation ...
Radiopharmaceuticals combine ligand-targeted delivery with systemically administered cytotoxic radiation, enabling site-of-disease effects while retaining the precision features of targeted therapy.
CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation investigations. Digital twins of cleanrooms are offering measurable reductions ...
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