Regulatory round-up: 11 May 2026

Drug regulators across major markets put safety, supply and post-market oversight at the centre of activity over the past week, with a US cancer-drug approval providing the main product-review headline while agencies in Europe, Brazil, Singapore, France and Ireland moved on recalls, shortages, enforcement and risk communication.

The Food and Drug Administration cleared Bizengri for adults with advanced NRG1 fusion-positive cholangiocarcinoma after prior systemic therapy, while also issuing final guidance on postapproval pregnancy safety studies for drugs and biologics. In Europe, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee completed its May meeting without opening or concluding a referral procedure, but several national agencies issued product-level actions.