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 ...

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 ...

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 ...

The European Commission announced on Tuesday the approval of the antibody lecanemab ... Lecanemab is sold under the brand name Leqembi. The drug is already authorized in the United States, UK ...

Biodexa Receives Orphan Drug Designation in Europe for eRapa in FAP. New designation follows the U.S. Food and Drug Administration (FDA) Orphan Drug Designation for ...

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

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

GW Pharmaceuticals’ cannabis-derived drug Epidyolex has been approved in Europe for two kinds of rare childhood epilepsy. The European Commission approved the drug, an oral solution containing ...

today announced that the European Commission (EC) has granted orphan drug designation for DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD). DYNE-251 is being evaluated in the Phase ...