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

New research from Bayes Business School, in collaboration with biopharmaceuticals company Merck KGaA, suggests member states from the European Union (EU) must work more closely together, provide ...

The drug receives conditional marketing authorization by the CHMP for the treatment of HER2-positive biliary tract cancer.

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's ...

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 ...

Aurobindo Pharma's biosimilar for breast cancer recommended for EU approval, demonstrating similarity to Herceptin.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance ...

EMA grants conditional marketing authorization to Italfarmaco’s Duvyzat to treat Duchenne muscular dystrophy: Amsterdam, The Netherlands Monday, April 28, 2025, 16:00 Hrs [IST] ...

Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular ...

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

HAS GRANTED ORPHAN DRUG DESIGNATION IN THE EUROPEAN UNION FOR AB8939 IN THE TREATMENT OF ACUTE MYELOID LEUKEMIA Paris, April 23, 2025, 6.45pm CET AB Science ...