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| Friday, November 28, 2025 |
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Eisai Submits New Drug Application for Subcutaneous Formulation of "LEQEMBI(R)" for the Treatment of Early Alzheimer's Disease in Japan |
| Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has filed a new drug application for "LEQEMBI(R)" (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). more info >> |
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| Wednesday, November 26, 2025 |
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Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) IQLIK(TM) (lecanemabirmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status |
| Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI(R)) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status. more info >> |
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| Monday, November 17, 2025 |
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"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in the United Kingdom |
| Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI(R)" (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. more info >> |
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| Thursday, October 30, 2025 |
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Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP012 Trial in Unresectable, Non-Metastatic Hepatocellular Carcinoma |
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| Tuesday, October 28, 2025 |
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Merck & Co., Inc. and Eisai Announce WELIREG(R) (belzutifan) Plus LENVIMA(R) (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma |
| more info >> |
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| Monday, October 27, 2025 |
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Health Canada Grants Authorization for "LEQEMBI(R)" (lecanemab) for the Treatment of Early Alzheimer's Disease |
| more info >> |
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| Tuesday, October 14, 2025 |
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LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Autoinjector Named to TIME's "Best Inventions of 2025" |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that LEQEMBI(R) IQLIK(TM), a subcutaneous autoinjector formulation of lecanemab (generic name), for the treatment of Alzheimer's disease (AD) has been selected by TIME as one of the "Best Inventions of 2025" in the Medical and Healthcare category. more info >> |
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| Wednesday, October 8, 2025 |
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Eisai and Biogen Announce U.S. Availability of LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI(R) IQLIK(TM) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). more info >> |
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| Friday, October 3, 2025 |
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Eisai Highlights Breadth of Oncology Research at ESMO 2025 |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2025, which is taking place in Berlin, Germany from October 17 to 21. more info >> |
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| Monday, September 29, 2025 |
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"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in China |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that humanized anti- soluble aggregated amyloid-beta (Abeta) monoclonal antibody "LEQEMBI(R)" (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China. more info >> |
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