FDA Warning Letter Novo Nordisk Reveals Serious Compliance Failures in Adverse Drug Reporting
The U.S. Food and Drug Administration (FDA) issued the FDA Warning Letter Novo Nordisk dated March 5, 2026, to Novo Nordisk Inc. (NNI)...
Methodological Gaps in Economic Evaluations of Vaccines: A Systematic Review
Economic evaluations of vaccines targeting multi-disease combinations, such as hepatitis A/B or measles-mumps-rubella (MMR), reveal critical methodological shortcomings in this systematic literature review. Synthesiz...
Enhertu Early Breast Cancer: FDA Priority Review for Reducing Recurrence Risk
Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, has received P...
Rapid Genetic Testing Mitigates Gentamicin-Induced Hearing Loss in Neonates
Rapid genetic testing is dramatically improving neonatal care by detecting the m.1555A>G mitochondrial variant in newborns at risk of profound hearing loss from gentamicin, allowing swift switches to alternative antibiotics without delaying treatment. Developed through the
EMA’s Clinical Trials Guidance for Enhancing Flexibility During Public Health Emergencies
The European Medicines Agency (EMA) has released draft clinical trials guidance for public consultation from 4 March to 30 April 2026. This guidance outlines regulatory flexibi...
Portugal Clinical Trials Regulation: A Comprehensive Framework for EU Compliance and Participant ...
Portugal Aligns with EU Standards
Portugal clinical trials regulation is now firmly established through Lei n.º 9/2026, published on March 6, 2026, which implements the European Parliament and Council







