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Amicus Therapeutics

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AstraZeneca’s Fasenra approved by EC to treat rare inflammatory disease EGPA

Eosinophilic granulomatosis with polyangiitis affects approximately 118,000 people globally

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Johnson & Johnson’s Yuvanci granted EC approval to treat pulmonary arterial hypertension

Yuvanci is now the only single tablet combination therapy for PAH patients in Europe

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Ipsen’s Kayfanda granted EC approval to treat cholestatic pruritus in Alagille syndrome

The rare genetic disorder affects approximately three in every 100,000 births globally

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Ipsen’s Iqirvo receives EC approval to treat primary biliary cholangitis in adults

The rare liver disease affects approximately nine women for every one man

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EC approves Bavarian Nordic’s mpox vaccine Imvanex for use in adolescents

More than 120 countries have confirmed over 103,000 cases of mpox since the global outbreak began in 2022

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GSK’s RSV vaccine Arexvy approved by EC for use in adults aged 50 to 59 years

An estimated 20 million adults in this age population are at an increased risk of severe RSV outcomes

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Roche’s monoclonal antibody PiaSky approved by EC to treat rare blood disorder PNH

The drug is now the first monthly subcutaneous treatment authorised for use in this patient population

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EC approves Celltrion’s Stelara biosimilar SteQeyma for inflammatory diseases

The drug has been authorised for use in gastroenterology, dermatology and rheumatology indications

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Johnson & Johnson’s Rybrevant combination approved by EC for expanded lung cancer use

Approximately 484,306 cases of lung cancer were diagnosed in Europe in 2022

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Merck’s Winrevair receives EC approval to treat pulmonary arterial hypertension in adults

About 30,000 people in the EU are living with the progressive blood vessel disorder

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Regeneron’s Ordspono granted EC approval to treat non-Hodgkin lymphomas

The decision marks the first regulatory approval of the drug globally for these patients

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J&J’s pan-FGFR kinase inhibitor Balversa approved by EC to treat bladder cancer

Up to 20% of patients with metastatic urothelial carcinoma have FGFR alterations

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