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- PMLiVE

J&J’s Darzalex recommended by CHMP to treat smouldering multiple myeloma

If approved, Darzalex would be the first therapy approved in the EU for SMM

- PMLiVE

AstraZeneca shares late-stage results for Airsupra in mild asthma patients

More than ten million asthma exacerbations occur in the US every year

- PMLiVE

AstraZeneca’s triple-combination COPD therapy shows promise in uncontrolled asthma

Up to 262 million people worldwide are affected by the chronic respiratory disease

- PMLiVE

Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

- PMLiVE

Rare diseases: Novartis’ Fabhalta recommended by CHMP for C3 glomerulopathy

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year

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Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa

There is currently only one treatment authorised for the ultra-rare genetic blistering disease

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CHMP recommends Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

Approximately 480,000 cases of the mosquito-borne viral disease were reported globally in 2024

- PMLiVE

Chiesi report highlights incorrect inhaler use among UK asthma patients

The long-term lung condition affects around 7.2 million people in the UK

- PMLiVE

Gilead and LEO enter inflammatory disease partnership worth up to $1.7bn

Targeting STAT6 has shown potential in treating a broad population of inflammatory disease patients

- PMLiVE

Gilead’s seladelpar recommended by CHMP to treat primary biliary cholangitis

The rare liver disease affects approximately 15 per 100,000 people in Europe

- PMLiVE

GSK’s Jemperli receives positive CHMP opinion for expanded endometrial cancer use

Approximately 121,000 people are diagnosed with primary advanced or recurrent endometrial cancer each year in Europe

- PMLiVE

MHRA urges companies to prepare for Windsor Framework for medicines

The new UK-wide arrangements for medicines will come into effect on 1 January 2025

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