Donanemab approval delayed by US drugs regulator
The American Food and Drug Administration (FDA) has announced an advisory panel will be convened to scrutinise data on the safety and efficacy of new Alzheimer’s drug donanemab. Donanemab had been expected to be approved by the FDA imminently, but their decision is now delayed until later this year.
UK regulators (along with their European and Australian counterparts) are still assessing the drug.
More information here: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-delays-lilly-alzheimers-drug-decision-calls-advisory-panel-2024-03-08/