Drug safety

FDA is requiring every GLP-1 receptor agonist label to carry a warning on NAION, a rare eye condition that can cause permanent vision loss. #SyenzaNews #drugsafety #GLP1

SMA Europe has relayed Novartis's figures on tumour reports in patients previously treated with Zolgensma, including two cases of vector DNA integration.

The Ministry of Food and Drug Safety hosts ICMRA, the international coalition of medicines regulators, in Seoul from 3 to 6 November 2026, with AI rules and alternatives to animal testing on the agenda. #SyenzaNews #MarketAccess #drugregulation

EMA's safety committee has opened a Deanxit safety review at Belgium's request, after reports of movement disorders and memory problems with the flupentixol/melitracen combination. The Belgian agency also questioned the benefit of combining the two substances. #SyenzaNews #Pharmacovigilance #EMA #MentalHealth

The FDA has launched the Neuroscience Advancement and Innovation Nexus, starting with an Alzheimer's Prevention Accelerator. #SyenzaNews #Alzheimers #MarketAccess

Sweden's pharmaceutical injury insurance logged 33 semaglutide adverse reactions claims in the first eight months of 2026, up from 13 in all of 2025. More prescribing and more awareness explain the rise better than any new risk. #SyenzaNews #pharmaceuticals #drugsafety #regulatoryaffairs

COMP's July 2026 sitting recommended 12 orphan drug designations, withdrew four, and sharpened the test for significant benefit against authorised therapies. #SyenzaNews #OrphanDrugs #MarketAccess #RareDiseases

WHO and St. Jude, with UNICEF and PAHO, have launched a 2026 to 2030 market-shaping strategy to improve access to childhood cancer medicines in low- and middle-income countries. #SyenzaNews #ChildhoodCancer #MarketAccess #Oncology

The FDA's landmark hearing on psychedelic medicines drew 80 speakers and 1,800 registrants, and the market access message was clear: approval is not access, and reimbursement is the binding constraint. #SyenzaNews #MarketAccess #Psychedelics #HealthPolicy

Every NCCN academic cancer center now reports a shortage of at least one anticancer medicine, led by ifosfamide (94%) and carboplatin (71%). Pharmacy directors say three years of policy have not moved the problem. #SyenzaNews #DrugShortages #Oncology #MarketAccess

The RECOVER-VITAL trial found nirmatrelvir-ritonavir offered no benefit for long COVID across cognitive, autonomic, or exercise symptoms. The study also shows why placebo controls matter: a large share of the placebo group improved on their own. #SyenzaNews #LongCOVID #ClinicalTrials #MarketAccess

Portugal medicinal cannabis exports reached 66,305 kg in the first half of 2026, according to INFARMED, already 83% of the 79,883 kg shipped across all of 2025. The country’s medicines regulator published the figures in its mid-year report on the sector, which also shows cultivation and manufacturing licences easing back after several years of rapid expansion. Portugal began regulating medicinal cannabis in 2018, when the Assembly of the Republic approved a law covering marketing authorisations, prescribing and pharmacy dispensing. A […]