Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myelomaRecommendation based on IMROZ ...

Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...

A key European regulatory panel has reversed course and is now recommending approval of Leqembi, the Alzheimer's drug from Biogen and Eisai. The companies on Thursday said the European Medicines ...

The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...

The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with ...

In Japan, clinical use is climbing faster, with about 4,500 people now on the drug. ARIA rates in Japan are half those in the U.S., which was also the case in the Phase 3 Clarity trial. Meanwhile, use ...

We fully endorse the Editorial1 on the negative opinion of the European Medicines Agency of the use of lecanemab for the treatment of early Alzheimer's disease. Investigators from the European ...

In a similar manner, member states must now pool their resources to address their shared geoeconomic concerns. To achieve ...

Baricitinib, an inhibitor of JAK1/2, was approved by both the FDA and European Medicines Agency in 2022 to treat moderate to ...

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give ... Already a ...