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 ...

Sanofi said that Sarclisa, its treatment for plasma cell cancer, was recommended for EU approval by the European Medicines Agency. The agency's Committee for Medicinal Products for Human Use ...

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 ...

has recommended granting marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment or mild dementia due to Alzheimer's disease," the European Medicines Agency said, adding ...