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Recommendations of the Higher Advisory Pharmacovigilance Committee HAPC Committee Decisions

Atomoxetine Risk Minimization Activity - New

SFDA Issues Warning Against Arrowhead Roast Beef Due to Listeria Contamination Warnings

An Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis with Moderate-to-Severe Pruritus Drug Clinical Trial

EASi-HF reduced – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40% Drug Clinical Trial

Upadacitinib Risk Minimization Activity - New

A Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Naïve to Targeted Therapies Drug Clinical Trial

Guidance for Combination Products Classification Regulations

SFDA Grants Orphan Drug Designation to "Agamree" for Duchenne Muscular Dystrophy News

Circular on Biological Products for Analytical Purpose Circulars