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Sanofi’s Enjaymo receives EC approval for rare autoimmune haemolytic anaemia

Cold agglutinin disease affects around 12,000 people in the US, Europe and Japan

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AstraZeneca/Sanofi’s Beyfortus receives EC approval for prevention of RSV in infants

The decision makes the antibody the first broadly protective option for this age population

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BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

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Kite’s CAR-T therapy Yescarta granted EC approval in second-line lymphoma

The decision is based on results from the phase 2 ZUMA-7 study

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EC approves Alexion’s Ultomiris as generalised myasthenia gravis treatment

The positive phase 3 trial results assessing the treatment were published in NEJM Evidence

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

Tezspire demonstrated superiority across every primary and key secondary endpoint compared to placebo

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AstraZeneca’s COVID-19 treatment granted EC approval

Evusheld significantly reduced risk of severe COVID-19 or death in a phase 3 trial

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Otsuka and Aurinia’s Lupkynis granted EC approval as active lupus nephritis treatment

The treatment is for use in combination with mycophenolate mofetil

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Roche’s Vabysmo receives EC approval to treat two leading causes of vision loss

60% of people treated with Vabysmo were able to extend treatment to every four months

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

Nuvaxovid induced a ‘robust antibody response’ when used as a heterologous third booster dose

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Novartis’ Scemblix receives EC approval for chronic myeloid leukaemia

It is estimated that more than 6,300 people will be diagnosed with CML in Europe every year

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Janssen’s teclistamab granted conditional marketing authorisation by EC

The decision makes teclistamab the first bispecific antibody worldwide to be approved for patients with relapsed and refractory multiple myeloma

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