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FDA Panel Overwhelmingly Rejects ALS Cell Therapy

Echoing concerns from agency reviewers, advisors can't find evidence of efficacy

United statesG caleb alexanderLisa leeGumei liuKathleen osullivan fortinNirali shahJudy georgeNational cancer institute in bethesdaJohns hopkins university in baltimoreGene therapy advisory committeeKathleeno sullivan fortinNational cancer instituteJohns hopkins universityBrainstorm cell therapeuticsVirginia techMedpage today

FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy

Data are 'scientifically incomplete' and manufacturing info is 'grossly deficient'

Judy georgeGene therapy advisory committeeBrainstorm cell therapeuticsMedpage today

bluebird bio reveals plans to launch two gene therapies

bluebird bio reveals plans to launch two gene therapies
pmlive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pmlive.com Daily Mail and Mail on Sunday newspapers.

Andrew obenshainCell tissue gene therapy advisory committeeDrug administrationCell tissueGene therapy advisory committeePrescription drug user act feeBiologics licensing application

Regular Blood Work After Gene Therapy Warranted by Rare Condition

Regular Blood Work After Gene Therapy Warranted by Rare Condition
medpagetoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medpagetoday.com Daily Mail and Mail on Sunday newspapers.

United statesBarry byrneNicole louDan levyDeepa chandRoland herzogGene therapy advisory committeeIndiana university school of medicineUniversity of floridaNovartis gene therapiesIndiana university schoolMedpage today

Keeping pace

Environmental risk, biosafety and other key regulatory considerations  for cell and gene therapy trials - Magazine Article - PharmaTimes

United kingdomExceptional technologyGene therapy advisory committeeVaccines expert advisory groupEuropean parliamentGene therapy modification safety committeeInstitutional biosafety committeeDrug administrationAdvisory committeeRegulatory agencyResearch advisory committee nexCommission declarationEuropean unionEuropean medicines agencyCommittee of advanced therapiesCouncil directive

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