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- PMLiVE

Eisai submits new drug application for subcutaneous Leqembi in Japan

LEQEMBI is a treatment for early Alzheimer’s disease

- 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

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

- PMLiVE

Biogen expands portfolio in deal with Alcyone Therapeutics

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

- PMLiVE

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

Biogen Idec building

Biogen/Eisai’s Alzheimer’s drug Leqembi shows continued benefit over four years

An estimated 13 million people in the US will be living with Alzheimer’s disease by 2050

- PMLiVE

Roche’s Evrysdi tablets approved by MHRA to treat spinal muscular atrophy

It is hoped the new formulation will offer patients greater freedom and flexibility compared to the liquid version

Biogen Idec building

Biogen’s Qalsody granted MHRA approval to treat rare form of motor neurone disease

Mutations in the SOD1 gene are responsible for approximately 2% of all cases of the disease

- PMLiVE

AbbVie’s Elahere granted MHRA approval to treat platinum-resistant ovarian cancer

Approximately 7,500 people are diagnosed with ovarian cancer every year in the UK

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