MHRA launches a consultation on indefinite recognition of CE-marked medical devices
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Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16th September 2025, approved the medicine vorasidenib (Voranigo).
Side effects from drug interactions to be predicted by AI before reaching patients
The MHRA leads three new government-backed projects using AI-driven approaches to make medicines safer and bring treatments to patients more quickly.
How medicines affect gut bacteria could inform safer, more effective use
Understanding gut microbiome interactions with medicines could help explain differences in how people respond to treatment and build on existing medicine safety knowledge to support safer, more effective prescribing in the future.
Field Safety Notices: 28 July to 1 August 2025
List of Field Safety Notices from 28 July to 1 August 2025.
Falsified Mounjaro KwikPen 15mg pre-filled pens
A falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection has been found supplied through one online pharmacy in the UK. The falsified product is labelled with batch D873576 and applies to Mounjaro KwikPen 15mg solution for injection in pre-filled pen only.
MHRA issues new guidance for people using mental health apps and technologies
New online resources will help the public, parents, carers and health, social care and education professionals understand what safe, effective digital mental health technologies look like in practice.