The European Medicines Agency has recommended marketing approval for Alyftrek for cystic fibrosis and Attrogy for a form of ...

The EMA has recommended extensions to the marketing authorizations for Adcetris, used to treat Hodgkin lymphoma, and ...

After developing treatments for rare tumors, SpringWorks Therapeutics is taking a buyout offer from Germany-based Merck KGaA.

There has never been “such positivity” about treatments for Alzheimer’s, and big changes will come in just a few months. This ...

Despite these benefits, biosimilar medicines remain under-recognised and underused in many markets. Real-world uptake often ...

Monoclonal antibody 'nirsevimab' highly effective in preventing severe RSV in infants, reducing hospitalisations and ICU ...

In the weeks to come, the European Commission will issue a decision on the first severe thyroid eye disease treatment.

On February 28, Praxis shared the results of a pre-planned interim analysis of Study 1. The Independent Data Monitoring ...

The company expects the European Commission (EC) to make a final decision on the marketing authorization in June 2025.

Merck KGaA acquires SpringWorks Therapeutics, Inc. for $3.9B, boosting its pipeline with OGSIVEO & GOMEKLI. Click for more on ...

In 2024, the European Medicines Agency (EMA) approved lecanemab for the treatment of early Alzheimer's disease in patients without contraindications or risk factors for side-effects. This approval ...

In addition, Eisai must conduct a post-authorization safety study, including setting up a patient registry for the European Union. Now each European country must set its own rules for access and ...