List of Field Safety Notices from 24 to 28 November 2025.
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MHRA approves inavolisib for the treatment of breast cancer
The MHRA has today, 26 November 2025, approved inavolisib (Itovebi) for the treatment of adults with a type of breast cancer called HR-positive
Consultation on the International Council for Harmonisation Guideline E20 for adaptive clinical trial design
The MHRA is consulting with UK stakeholders to gather feedback and comments on ICH E20, a new international guideline.
Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation
New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.
Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01
Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent inspection at the finished product manufacturing site.
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).
MHRA Safety Roundup: January 2026
Summary of the latest safety advice for medicines and medical device users