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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.

United kingdomUnited statesKris kowdleyChristelle huguetIpsen iqirvoLiver instituteHealthcare products regulatory authorityDrug administrationEuropean medicines agencyAmerican associationLiver diseaseLiver institute northwestEuropean associationUnited kingdom medicinesHealthcare products regulatoryBreakthrough therapy designation

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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