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drug approval delays

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Almirall’s paediatric registration of Ebglyss for atopic dermatitis gets EMA acceptance

Atopic dermatitis affects a significant number of children and adolescents and often peaks in childhood

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Regeneron’s New Drug Application for cemdisiran accepted for review by FDA and EMA

Globally, around 150 to 200 out of every million people have myasthenia gravis

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EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

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MHRA authorises Biogen’s higher-dose Spinraza for SMA treatment

SMA is a rare genetic neuromuscular condition affecting around 1,600 people in the UK

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Astellas’ application to EMA validated for treatment of muscle-invasive bladder cancer

Bladder cancer affects over 224,000 people annually in Europe, with over 30% of cases being muscle-invasive bladder cancer

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EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

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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

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MHRA approves Leqselvi for severe alopecia areata

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

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

Obesity affects approximately 15 million people in the UK

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GSK’s Nucala approved by MHRA for uncontrolled COPD

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

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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

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MHRA marks 100 years of patient safety through biological standards

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

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