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Japan – Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for the Indication of Amyotrophic Lateral Sclerosis

Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of...
Business

Japan – Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor...
Business

SinoMab Submits another IND Application for SM17 for the Treatment of Atopic Dermatitis, Which was Accepted by NMPA CDE

A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases - SinoMab BioScience...
Business

Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO – WEBWIRE – Friday,...
Business

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Great Britain

Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a Marketing Authorization Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ)...
Business

Japan – Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name...
Business

Japan – Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration...
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