Safety news
News briefs
Short summaries of drug safety and pharmacovigilance news from regulators and industry, with links to the sources, newest first.
FDA investigates Zolgensma and Itvisma tumour risk; FDA highlights DPD deficiency labelling for capecitabine and 5-FU; Health Canada warns of bacteria in unauthorized injectable peptides.
Read brief: Drug safety daily: FDA on Zolgensma tumours, DPD testing for fluoropyrimidines, contaminated peptidesMHRA interim cardiac advice for Duvyzat after international deaths; Novartis reports tumours after Zolgensma; TGA finds Synedica peptides mislabelled; FDA warns on residual platelet sepsis risk.
Read brief: Drug safety daily: Duvyzat deaths monitoring, Zolgensma tumours, peptide lab findingsRespreeza vial closure DHPC in the EU and Switzerland, Swissmedic centralises mandated safety material, Medsafe warns on unapproved peptides.
Read brief: Drug safety daily: Respreeza vial defect, Swiss risk-minimisation platform, peptide warningEMA sets out GVP IX signal changes, a PSUSA pilot and ICSR compliance findings; FDA finalises CGT potency guidance; Canada recalls a cyclophosphamide lot.
Read brief: Drug safety daily: EU signal and PSUR changes, ICSR compliance, CGT potency guidanceFDA partially holds a pediatric BMB-101 epilepsy trial over mouse toxicity; Swissmedic's November label updates; MHRA opens #MedSafetyWeek 2026.
Read brief: Drug safety daily: a pediatric partial hold, Swissmedic label updates and #MedSafetyWeekPRAC opens a Deanxit referral and an immunoglobulin hypersensitivity signal; FDA weighs a mitapivat REMS; Gilead CAR-T trials on partial hold.
Read brief: Drug safety daily: PRAC immunoglobulin signal, Deanxit review and a CAR-T holdFor longer analysis and case studies, see the news and articles, or follow Safety Strategy on LinkedIn (opens in a new tab).