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FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC

The accelerated approval is based on data from the phase 3 ELATIVE trial demonstrating a reduction in alkaline phosphatase with elafibranor.

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FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer s Disease

FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer s Disease
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FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb)

FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb)
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Biogen Inc : FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer s Disease

TOKYO and CAMBRIDGE, Mass., June 09, 2024 (GLOBE NEWSWIRE) Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts

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Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted Therapy for PTSD

/PRNewswire/ Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug.

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