Celltrion, a major Korean biopharmaceutical firm, said Monday its new biosimilar for an autoimmune disease treatment has ...

Ionis Pharmaceuticals’ RNA-targeted drug Waylivra ... approved in Europe for the devastating ultra-rare disease Familial Chylomicronemia Syndrome (FCS). The European Commission’s conditional ...

Eisai Co., Ltd. and Biogen Inc. announced that the European Commission has granted marketing ... or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse ...

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 ...

The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...

Regeneron’s bispecific antibody linvoseltamab has received conditional approval from the European Commission (EC) for use in relapsed or refractory multiple myeloma. The decision comes just eight ...

RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU) to treat adult patients with giant cell arteritis (GCA)The approval is supported by ...

Krystal Biotech ( NASDAQ: KRYS) said that the European Commission granted marketing authorization to Vyjuvek for the treatment of wounds in certain patients with dystrophic epidermolysis bullosa, or ...

PITTSBURGH, April 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that on April 23, 2025, the European Commission (EC) granted marketing ...

Eisai Co.’s breakthrough Alzheimer’s drug Leqembi was cleared for use in the European Union, after the medicine was approved in the US and Japan. The European Commission approved the drug to ...