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- PMLiVE

MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis

The changes to the terms were also approved by the EC in October

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Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer

The treatment will be made available immediately through an early access deal with NHS England

- PMLiVE

Novavax’s COVID-19 vaccine receives MHRA approval for use as a booster

Nuvaxovid was shown to increase antibody levels when used as a third booster

- PMLiVE

MSD’s Vaxneuvance approved by MHRA for prevention of pneumococcal diseases in children

The decision marks the first new vaccine approved by MHRA in a decade for this indication

- PMLiVE

Pfizer/BioNTech’s second bivalent COVID-19 booster approved by MHRA

The adapted vaccine targets the original virus and Omicron BA.4 and BA.5 strains

- PMLiVE

Novartis’ Cosentyx receives MHRA approval for two types of juvenile idiopathic arthritis

A phase 3 trial showed significantly longer time to flare for both JPsA and ERA patients

- PMLiVE

AstraZeneca’s Tezspire receives MHRA approval as add-on treatment for severe asthma

Tezspire demonstrated reduced annualised rate of asthma exacerbations

- PMLiVE

Pfizer/BioNTech BA.1 COVID-19 booster receives CHMP recommendation

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

Moderna’s Omicron BA.1 targeting bivalent booster recommended by CHMP for use in EU

Results from a phase 2/3 trial demonstrated mRNA-1273.214 had superior neutralising antibody response against Omicron compared to the currently authorised booster

- PMLiVE

Novavax’s COVID-19 vaccine candidate approved by MHRA for adolescents aged 12 to 17

Data from an ongoing phase 3 paediatric trial demonstrated Nuvaxovid produced 80% clinical efficacy in this age group

- PMLiVE

Moderna’s Omicron booster receives MHRA approval

The booster dose can be used in adults aged 18 years and over to protect against contracting COVID-19

- PMLiVE

Novartis’ Pluvicto receives MHRA marketing authorisation to treat advanced prostate cancer

The approval for the treatment applies to England, Scotland and Wales

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