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antibody therapy

- PMLiVE

Sanofi and Regeneron’s Dupixent receives positive NICE final draft guidance for COPD

Around 1.4 million people in the UK are diagnosed with COPD, with two million thought to be undiagnosed

- 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

Regeneron’s Libtayo receives EC approval for skin cancer

Phase 3 trial results showed the drug significantly improved disease-free survival

- 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

Invivyd working with FDA towards potential Biologics License Application for COVID-19

The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

- 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

- PMLiVE

FDA approves Pfizer and BioNTech’s jab for COVID-19

Globally, five billion doses of the companies’ vaccine have been distributed

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