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gene therapy
Moderna's gene therapy expansion picks up pace with $76M upfront Generation Bio collab
Moderna's gene therapy expansion picks up pace with $76M upfront Generation Bio collab
Fierce Biotech
Moderna Therapeutics
gene therapy
Generation Bio
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FDA's Peter Marks backs accelerated approval for gene therapies
FDA's Peter Marks backs accelerated approval for gene therapies
BioSpace
FDA
CDER
Peter Marks
gene therapy
accelerated approval
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Novartis: SMA Drug Zolgensma Long-term Data Shows Sustained Durability Up To 7.5 Years Post-dosing
Novartis: SMA Drug Zolgensma Long-term Data Shows Sustained Durability Up To 7.5 Years Post-dosing
NASDAQ
Novartis
SMA
Zolgensma
gene therapy
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FDA Reverses Course; Will Hold Adcomm for Sarepta’s DMD Gene Therapy
FDA Reverses Course; Will Hold Adcomm for Sarepta’s DMD Gene Therapy
BioSpace
FDA
Sarepta Therapeutics
DMD
gene therapy
Duchenne Muscular Dystrophy
SRP-9001
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Duchenne muscular dystrophy: major trials and events to watch in 2023
Duchenne muscular dystrophy: major trials and events to watch in 2023
Clinical Trials Arena
DMD
Duchenne Muscular Dystrophy
clinical trials
gene therapy
FDA
Sarepta Therapeutics
SRP-9001
FibroGen
pamrevlumab
Capricor
CAP-1002
Santhera
ReveraGen
vamorolone
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CRISPR/ViaCyte and Genprex Vie for First Diabetes Gene Therapy
CRISPR/ViaCyte and Genprex Vie for First Diabetes Gene Therapy
BioSpace
ViaCyte
CRISPR Therapeutics
Genprex
diabetes
gene therapy
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FDA delays review of BioMarin's hemophilia gene therapy after data update
FDA delays review of BioMarin's hemophilia gene therapy after data update
Endpoints
Biomarin
gene therapy
hemophilia A
FDA
valrox
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Sarepta: FDA finds ‘no significant safety issues of concern’ with DMD gene therapy
Sarepta: FDA finds ‘no significant safety issues of concern’ with DMD gene therapy
Biopharma Reporter
Sarepta Therapeutics
DMD
Duchenne Muscular Dystrophy
gene therapy
FDA
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Sangamo scraps public offering ‘after evaluating market conditions’
Sangamo scraps public offering ‘after evaluating market conditions’
Endpoints
Sangamo
stock offering
cell therapy
gene therapy
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Spark Breaks Ground on Gene Therapy Innovation Center on Drexel Campus in Philadelphia
Spark Breaks Ground on Gene Therapy Innovation Center on Drexel Campus in Philadelphia
BioBuzz
Spark Therapeutics
gene therapy
Philadelphia
Drexel University
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CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies
CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies
Endpoints
CBER
Peter Marks
FDA
gene therapy
cell therapy
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Sarepta's DMD gene therapy inches closer to market as FDA declines to hold advisory meeting
Sarepta's DMD gene therapy inches closer to market as FDA declines to hold advisory meeting
Fierce Biotech
FDA
Sarepta Therapeutics
SRP-9001
gene therapy
DMD
Duchenne Muscular Dystrophy
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FDA plans to launch communications pilot for promising rare disease gene therapies
FDA plans to launch communications pilot for promising rare disease gene therapies
RAPS.org
FDA
biologics
gene therapy
Rare Diseases
regulatory
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AbbVie, Capsida Set Sights on Gene Therapies for Eye Diseases
AbbVie, Capsida Set Sights on Gene Therapies for Eye Diseases
BioSpace
AbbVie
Capsida Biotherapeutics
gene therapy
eye disease
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First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission
First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission
BioSpace
CSL
Europe
Hemgenix
gene therapy
hemophilia B
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'It's the right call': GSK expresses no regrets on abandoning cell therapy as oligo strategy heats up
'It's the right call': GSK expresses no regrets on abandoning cell therapy as oligo strategy heats up
Fierce Biotech
GSK
cell therapy
gene therapy
oligonucleotides
Wave Life Sciences
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A renewed push into early bladder cancer
A renewed push into early bladder cancer
EP Vantage
Ferring Pharmaceuticals
Adstiladrin
FDA
gene therapy
bladder cancer
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Taysha’s GAN Gene Therapy Hits FDA Speedbump
Taysha’s GAN Gene Therapy Hits FDA Speedbump
BioSpace
Taysha Gene Therapies
TSHA-120
axonal neuropathy
clinical trials
gene therapy
FDA
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Amid application tsunami, FDA's top cell and gene therapy leader to retire in March
Amid application tsunami, FDA's top cell and gene therapy leader to retire in March
Endpoints
FDA
gene therapy
cell therapy
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UniQure nabs another gene therapy for ALS
UniQure nabs another gene therapy for ALS
BioPharma Dive
UniQuire
Apic Bio
ALS
gene therapy
AMT-162
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