Every month we check 4 pharmaceutical industry regulatory bodies (the FDA, European Commission, MHRA, and HPRA) and bring together their news into one handy update.
Round up of Regulatory News from November 2025
FDA news from November 2025
- 5 November – FDA Warns Companies Over Illegal Marketing of Botox and Related Products
- 10 November – HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
- 14 November – FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
- 24 November – FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy
European Commission news from November 2025
MHRA news from November 2025
- 2 November – Major change for rare disease treatments on way, signals MHRA
- 3 November – MHRA calls on public to report side effects and suspected fakes during #MedSafetyWeek
- 6 November – MHRA approves Siiltibcy as a diagnostic aid for Mycobacterium tuberculosis infection, including disease
- 11 November – MHRA-led study reveals major inconsistencies in global microbiome research
- 18 November – Multi-million pound backing for cutting edge projects by UK scientists and innovators
- 19 November – Professor Alastair Denniston: The future regulation of AI in healthcare
- 24 November – MHRA reaffirms safety of childhood vaccination
- 26 November – MHRA approves inavolisib for the treatment of breast cancer
- 27 November – MHRA and NICE receive £2 million from Wellcome to improve safety and effectiveness of digital mental health technologies
- 27 November – New MHRA-supported research reveals patterns of vaccine-derived poliovirus spread and implications for global eradication efforts
HPRA news from November 2025
References
European Commission – https://health.ec.europa.eu/medicinal-products/latest-updates_en
FDA – https://www.fda.gov/news-events/fda-newsroom/press-announcements
HPRA – https://www.hpra.ie/news-events/news
MHRA – https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
About the Author
Claire Wilson
Content Marketing and Career Coaching
Claire runs GetReskilled’s Advanced Career Coaching Programme – our specially devised job hunting course that helps our trainees take that final step into employment by leading them through the job hunting process. She is extremely enthusiastic about helping people reach their final goal of employment in their new career path.
Claire has a BSc (Hons) in Medical Biology from Edinburgh University and spent 7 years working in the pharmaceutical and medical device industries.
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