Duchenne Muscular Dystrophy

FibroGen’s Duchenne drug misses mark in first large trial
FibroGen’s Duchenne drug misses mark in first large trial
BioPharma Dive
FibroGen
clinical trials
Duchenne Muscular Dystrophy
pamrevlumab
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FDA delays decision on Duchenne gene therapy and considers narrower approval
FDA delays decision on Duchenne gene therapy and considers narrower approval
BioPharma Dive
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
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Sarepta Enters Uncharted Territory with Adcomm Approval
Sarepta Enters Uncharted Territory with Adcomm Approval
BioSpace
Sarepta Therapeutics
SRP-9001
DMD
Duchenne Muscular Dystrophy
FDA
gene therapy
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FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy
FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy
Fierce Biotech
Sarepta Therapeutics
FDA
DMD
gene therapy
Duchenne Muscular Dystrophy
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FDA reviewers flag concerns over Sarepta's gene therapy for DMD
FDA reviewers flag concerns over Sarepta's gene therapy for DMD
Yahoo/Reuters
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
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Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm
Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm
Fierce Biotech
Sarepta Therapeutics
FDA
SRP-9001
DMD
Duchenne Muscular Dystrophy
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Go or no go? Sarepta’s gene therapy faces scrutiny
Go or no go? Sarepta’s gene therapy faces scrutiny
EP Vantage
Sarepta Therapeutics
gene therapy
SRP-9001
Roche
DMD
Duchenne Muscular Dystrophy
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Sarepta shares drop as report says FDA almost rejected under-review gene therapy
Sarepta shares drop as report says FDA almost rejected under-review gene therapy
Yahoo/Reuters
Sarepta Therapeutics
FDA
gene therapy
DMD
Duchenne Muscular Dystrophy
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Chasing Pfizer and Roche, Regenxbio benefits from FDA boost for DMD gene therapy
Chasing Pfizer and Roche, Regenxbio benefits from FDA boost for DMD gene therapy
Fierce Biotech
Regenxbio
adeno-associated viruses
Duchenne Muscular Dystrophy
FDA
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5 FDA decisions to watch in the second quarter
5 FDA decisions to watch in the second quarter
BioPharma Dive
FDA
Sarepta Therapeutics
Duchenne Muscular Dystrophy
Biogen
tofersen
ALS
Seres Therapeutics
C. difficile
Pfizer
GSK
vaccines
RSV
Regeneron
Eylea
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Vertex flexes its dealmaking muscle
Vertex flexes its dealmaking muscle
EP Vantage
Vertex Pharmaceuticals
Entrada Therapeutics
Tevard Biosciences
Duchenne Muscular Dystrophy
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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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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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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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Vertex tiptoes further into Duchenne research with Tevard deal
Vertex tiptoes further into Duchenne research with Tevard deal
BioPharma Dive
Vertex Pharmaceuticals
Duchenne Muscular Dystrophy
DMD
Tevard Biosciences
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Duchenne muscular dystrophy’s progress so far in 2023
Duchenne muscular dystrophy’s progress so far in 2023
Clinical Trials Arena
Duchenne Muscular Dystrophy
DMD
Santhera Pharmaceuticals
ReveraGen
vamorolone
Regenxbio
RGX-202
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FDA accepts Santhera, ReveraGen’s vamorolone NDA to treat DMD
FDA accepts Santhera, ReveraGen’s vamorolone NDA to treat DMD
Pharmaceutical Business Review
Santhera Pharmaceuticals
ReveraGen
vamorolone
Duchenne Muscular Dystrophy
FDA
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Sarepta marches forward with its potential DMD gene therapy and an expanded Catalent manufacturing deal
Sarepta marches forward with its potential DMD gene therapy and an expanded Catalent manufacturing deal
Endpoints
Sarepta Therapeutics
SRP-9001
gene therapy
Duchenne Muscular Dystrophy
CDMOs
Catalent
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Fresh from Vertex payday, Entrada's DMD plans are derailed by FDA hold
Fresh from Vertex payday, Entrada's DMD plans are derailed by FDA hold
Fierce Biotech
Entrada Therapeutics
Vertex Pharmaceuticals
FDA
clinical trials
Duchenne Muscular Dystrophy
myotonic muscular dystrophy
ENTR-601-44
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