“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (GLOBE NEWSWIRE) -- 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 (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance do...
LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Australia TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- 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 the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild d...
Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company’s supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA. The letter did not cite any deficiencies in the c...
Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs)ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders. CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Inc. (Nasdaq: BIIB) announced the company has entered into a definitive agreement to acquire Massachusett...
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPDThe EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive...
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasd...
Biogen and Stoke Therapeutics Present Data at the 36th International Epilepsy Congress that Support the Potential for Zorevunersen to be the First Disease-Modifying Medicine for Dravet Syndrome – Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension studies – – Substantial increase in seizure-free days and continuous improvements in quality of life demonstrated in patients already taking standard of care anti-seizure medicines – – Zorevunersen generally well tolerat...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.