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 December 2025
FDA news from December 2025
- 3 December – FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity
- 4 December – FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US
- 8 December – FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia
- 9 December – FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome
- 12 December – FDA Approves Two Oral Therapies to Treat Gonorrhea
- 15 December – FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
European Commission news from December 2025
- 12 December – New medicine to treat non-muscle invasive bladder cancer
MHRA news from December 2025
- 2 December – MHRA approves tisotumab vedotin for the treatment of cervical cancer
- 6 December – Hepatitis B vaccines for babies
- 11 December – Mirdametinib approved to treat plexiform neurofibromas in children, adolescents, and adults with neurofibromatosis type 1
- 12 December – UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies
- 15 December – European first as MHRA approves over-the-counter allergy treatment for adolescents aged 12 and over
- 15 December – UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps
- 19 December – MHRA approves lenacapavir for the prevention of sexually transmitted HIV-1 infection
HPRA news from December 2025
No updates
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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