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Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for lupus

Therapies like topical steroids manage symptoms but there is currently no cure

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Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

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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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Eisai submits new drug application for subcutaneous Leqembi in Japan

LEQEMBI is a treatment for early Alzheimer’s disease

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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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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

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Ipsen’s tumour treatment receives MHRA marketing authorisation

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

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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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Biogen expands portfolio in deal with Alcyone Therapeutics

The agreement gives Biogen full rights to a potential therapy for patients with neurological disorders

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UK’s first new type of antibiotic for UTIs in nearly 30 years approved by MHRA

The oral pill is effective against many drug-resistant infections, including E. coli

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