Prescription Drug User Fee Act News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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
tmcnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from tmcnet.com Daily Mail and Mail on Sunday newspapers.

United statesSouth koreaUnited kingdomSaudi arabiaHong kongGreat britainJulie edelmanHaruo naitoChristophera viehbacherTsujim protofibrilsJack coxChuck trianoAlzheimer clinical trial consortiumPublic relations departmentCommunications departmentNational institutes of health

FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb)

FDA Accepts Eisai s Filing of LEQEMBI® (lecanemab-irmb)
globenewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from globenewswire.com Daily Mail and Mail on Sunday newspapers.

United statesHong kongUnited kingdomSaudi arabiaSouth koreaGreat britainJulie edelmanJack coxChristophera viehbacherChuck trianoTsujim protofibrilsHaruo naitoUnited nations sustainable development goals sdgsEisai europe ltdNational institutes of healthBiogen inc

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

United kingdomHong kongUnited statesSouth koreaSaudi arabiaGreat britainChuck trianoChristophera viehbacherLinkedinand facebookTsujim protofibrilsJack coxHaruo naitoJulie edelmanDrug administrationEuropean unionUnited nations sustainable development goals sdgs

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.

United statesDavide entactogensAmy emersonJerry rosenbaumClin neurosciUs armyVa national centerNational institute on drug abuseWorld mental healthDrug administrationHealth psycholNational epidemiologic survey on alcoholUs department of veterans affairsAmerican psychological associationHospital research instituteWorld health organization