JCN Newswire
TOKYO and CAMBRIDGE, Mass., Nov 1, 2024 – (JCN Newswire) – Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA…
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Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Under the Fast Track Status
TOKYO and CAMBRIDGE, Mass., Nov 1, 2024 – (JCN Newswire) – Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was