The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, ...

CHMP recommends approval of Regeneron's Lynozyfic, Krystal's Vyjuvek, Accord's trabectedin, Takeda's Deqsiga, and 16 label ...

Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) announcement that its Committee for Medicinal ...

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study1,2 DLBCL—an ...

Valneva (VALN) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive ...

Janssen-Cilag International NV, a Johnson & Johnson company (NYSE:JNJ) announced Friday that an expert panel of the EU drug ...

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo said on Friday that the European Medicines Agency (EMA) endorsed ENHERTU for the ...

Approval would expand the use of Enhertu to breast cancer patients with nearly undetectable HER2 levels in their tumors.

Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.

Vertex Pharmaceuticals (VRTX) stock in focus as company secures EU backing to expand label for its cystic fibrosis therapy Kaftrio. Read more here.