Pharmaceutical Regulatory Authorities – News & Updates (2026)

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.

Clicking on any of the links below will take you directly to the regulator’s own website where you can read the related story.

• 1 April – FDA Approves First New Molecular Entity Under National Priority Voucher Program
  
• 13 April – FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
• 14 April – FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
• 16 April – FDA Takes Step Forward on Testosterone Therapy for Men
• 20 April – FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
• 23 April – CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
• 23 April – FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
• 24 April – FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
• 28 April – FDA Announces Major Steps to Implement Real-Time Clinical Trials
• 30 April – FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
• 30 April – FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

• 15 April – Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics
• 22 April – Commission authorises first combined COVID-19 and influenza vaccine for people 50 years and older

• 2 April – Sevabertinib approved to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery
• 2 April – UK and US deepen regulatory cooperation on medical devices, building on wider pharmaceutical partnership
• 8 April – MHRA expands AI Airlock programme with a £3.6 million funding boost over three years
• 10 April – MHRA approves olezarsen (Tryngolza) for the treatment of familial chylomicronemia syndrome
• 14 April – Single-dose 7.2mg semaglutide (Wegovy) pen approved to treat adult patients with obesity
• 20 April – Precautionary recall of blood pressure medication after manufacturing error
• 22 April – Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
• 23 April – Precautionary recall of medication used for pain and inflammation due to incomplete patient information
• 27 March – Launch of clinical trial reforms
• 28 April – Precautionary recall of antidepressant medication due to manufacturing error

• No updates

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