Multiple Acyl Coenzyme A Dehydrogenase Deficiency
EMA Reverses Decision, Recommends Approval of Lecanemab (Leqembi) for Early Alzheimer’s Disease in Specific Patient Group
Lecanemab, Leqembi, Alzheimer’s disease, EMA, CHMP, early Alzheimer’s disease, ApoE ε4, amyloid-beta monoclonal antibody
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
European Medicines Agency Investigates Potential Link Between Hair Loss Drugs and Suicidal Thoughts
EMA, hair loss drugs, finasteride, dutasteride, suicidal thoughts, psychiatric side effects, European Medicines Agency
FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval
FDA, Dupixent, COPD, EMA, Regeneron, Sanofi, Priority Review, PDUFA, Boreas, Notus, Phase III Trials
EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New
EMA, GLP-1 receptor agonists, Diabetes and weight-loss drugs, Suicidal ideation risk, No causal association, Pharmacovigilance activities, Continued monitoring