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European Commission

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Takeda announces EC approval for Adcetris combination in Hodgkin lymphoma

The ADC has been approved alongside doxorubicin, vinblastine and dacarbazine

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Pfizer’s Litfulo approved by EC for adults and adolescents with severe alopecia areata

The autoimmune disease affects approximately 147 million people globally

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EC approves Otsuka and Astex’s Inaqovi for acute myeloid leukaemia

Inaqovi is the first oral hypomethylating agent approved for this patient population

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BioMarin announces first patient dosed with haemophilia A gene therapy in Europe

The therapy was granted conditional marketing authorisation by the EC in August 2022

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Merck receives EC approval for Keytruda combination in gastric cancer

Over one million new cases of gastric cancer were diagnosed globally in 2020

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Roche’s spinal muscular atrophy therapy Evrysdi approved by EC for newborns

The neuromuscular disease affects approximately one in every 10,000 babies

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Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

The decision allows Abrysvo to be given to those who are 24 to 36 weeks into their pregnancy

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Bristol Myers Squibb’s Opdivo approved by EC for expanded melanoma use

The global incidence of skin cancer has been rising steadily over the past few decades

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Janssen’s Tecvayli approved by EC for reduced dosing frequency in multiple myeloma

Tecvayli was the first BCMA-targeting bispecific antibody to be approved in Europe

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EMA reports actions to improve EU clinical trials conducted during health emergencies

All proposed actions will be acknowledged by the European Commission, EMA and member states

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EU establishes €100m funding scheme for projects tackling public health threats

The HERA Invest fund will focus on health emergency prevention and preparedness initiatives

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Roche’s fixed-duration lymphoma treatment approved by European Commission

Approximately 36,000 people are diagnosed with DLBCL each year in Europe

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