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UK clinical trial regs are changing — here’s what’s happening

Discover the transformative updates to UK clinical trial regulations, effective from April 2026, and learn how they aim to enhance transparency, participant safety, and trial efficiency.

Cuttsy + Cuttsy

- PMLiVE

MHRA approves Leqselvi for severe alopecia areata

Around 30% of patients saw 80% more scalp hair after 24 weeks of treatment

- PMLiVE

GSK to acquire 35Pharma for $950m including a potential drug for pulmonary hypertension

PH has a five‑year survival rate of only around 50% and affects up to 82 million people worldwide

- PMLiVE

GSK’s Arexvy RSV vaccine receives expanded EC approval for use in adults

RSV affects approximately 64 million people around the world each year

- PMLiVE

Novo Nordisk’s Wegovy higher dose injection approved by UK MHRA for obesity

Obesity affects approximately 15 million people in the UK

- PMLiVE

GSK’s Nucala approved by MHRA for uncontrolled COPD

Symptoms of COPD include breathlessness, persistent cough and frequent chest infections

- PMLiVE

Biogen and Eisai receive MHRA approval for updated dosing of early Alzheimer’s treatment

The MHRA approval for IV dosing comes following positive results from the global phase 3 trial

- PMLiVE

GSK’s Blenrep approved by FDA for multiple myeloma

Approval supported by positive results from phase 3 trial

- PMLiVE

MHRA marks 100 years of patient safety through biological standards

The UK regulator highlights its century-long role in establishing safety and consistency benchmarks

- PMLiVE

MHRA and FDA expand collaboration on AI and medtech regulation

National Commission on the Regulation of AI in Healthcare brings together UK and US experts

- PMLiVE

Ipsen’s tumour treatment receives MHRA marketing authorisation

This is the first approval in the UK for previously treated advanced neuroendocrine tumours

- PMLiVE

New National Commission launched to strengthen AI regulation

The Commission will unite healthcare leaders, regulators and technology experts to shape future AI governance

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