April 15, 2026
ATMPs are dynamic, often patient‑specific, and designed to achieve durable or even curative effects through permanent genetic modification, cellular engraftment, or tissue regeneration.
ATMPs are dynamic, often patient‑specific, and designed to achieve durable or even curative effects through permanent genetic modification, cellular engraftment, or tissue regeneration.
It occurs when patients experience adverse symptoms solely because they expect them, rather than due to the pharmacological action of a drug.
New aspect of a known risk (aseptic meningitis in healthy young adults following live attenuated chikungunya vaccination), a new adverse reaction for an established acetylcholinesterase inhibitor (nightmares with galantamine), and a request for supplementary information on the increased risk of ectopic pregnancy with lower-dose levonorgestrel intrauterine devices (13.5 mg).
A label update from the New Zealand regulatory authority (Medsafe) regarding Pisa syndrome associated with donepezil and other medicines. Two local Individual Case Safety Reports (ICSRs) of urinary incontinence following isotretinoin use, with a positive rechallenge in one case.
This article provides a detailed medical and scientific overview of VigiBase, based on the 2026 resource profile update published by UMC researchers. It covers the database’s history, data collection and processing workflows, coding standards (WHODrug Global and MedDRA), analytical tools (including vigiMatch, vigiGrade, vigiRank, and the VigiBase pregnancy algorithm), and key descriptive statistics....
The European Medicines Agency (EMA), through its Committee for Veterinary Medicinal Products (CVMP), has established comprehensive guidance for risk management plans (RMPs) for novel therapy veterinary medicinal products (NT-VMPs).
Artificial intelligence (AI) is transforming pharmacovigilance. From automated case processing to signal detection and duplicate identification, AI systems promise to enhance efficiency, improve quality, and enable entirely new capabilities. However, the rapid proliferation of AI tools—coupled with decreasing development costs—creates a critical challenge: how do we know which AI systems actually work?
Advancing Medication Safety Through Knowledge and Vigilance