Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of ...

The FDA has started its review of a subcutaneous injection formulation of Eisai and Biogen's Alzheimer's drug Leqembi that could allow patients to receive maintenance doses at home, rather than in ...

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Genentech also markets Lucentis, a ranibizumab that is administered through a direct injection into the eye. Genentech had recalled the ocular implant, the insertion tool and initial fill kit in the ...

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The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance regimen of Leqembi ® (lecanemab-irmb ...

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From pioneering early industrial gripper systems to mastering Metal Injection Moulding, Germany’s Zimmer Group is today a leader in advanced automation and manufacturing technologies. With operations ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.