The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, ...
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, ...
Caliway Biopharmaceuticals (Caliway), a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics, has announced that ...
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 ...
A European Medicines Agency committee had said in July that the medicine, called Leqembi, should be rejected, citing the ...
Baricitinib, an inhibitor of JAK1/2, was approved by both the FDA and European Medicines Agency in 2022 to treat moderate to ...
NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (" NurExone " or the " Company "), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce ...
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