Sarepta Therapeutics

Go or no go? Key FDA decisions for Argenx and Regeneron
Go or no go? Key FDA decisions for Argenx and Regeneron
EP Vantage
FDA
Albireo Pharma
Aldeyra Therapeutics
Alvotech
Amneal Pharmaceuticals
Argenx
ARS Pharmaceuticals
AstraZeneca
Bayer
Bio-Thera Solutions
Biogen
BioMarin Pharmaceutical
Bristol Myers Squibb
Eisai
Eton Pharmaceuticals
F2G
Fabre-Kramer Pharmaceuticals
Fresenius
GSK
Intercept Pharmaceuticals
Ipsen
Ironwood Pharmaceuticals
Merck
Novaliq
Pfizer
Regeneron
Roche
Sanofi
Sarepta Therapeutics
Shionogi
Swedish Orphan Biovitrum
Takeda
Teva Pharmaceutica
UCB Pharma
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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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2023’s biggest launches: the story so far
2023’s biggest launches: the story so far
EP Vantage
drug launches
AbbVie
Almirall
Apellis Pharmaceuticals
Astellas
AstraZeneca
Biogen
CRISPR Therapeutics
Daiichi Sankyo
Eli Lilly
Genmab
GSK
Iveric Bio
Pfizer
Roche
SAGE Therapeutics
Sanofi
Sarepta Therapeutics
Shionogi
Swedish Orphan Biovitrum
Vertex Pharmaceuticals
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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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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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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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Biopharma's stock market winners of 2022 revealed
Biopharma's stock market winners of 2022 revealed
EP Vantage
pharma stocks
Merck
Eli Lilly
AbbVie
Daiichi Sankyo
Vertex Pharmaceuticals
Takeda
Sarepta Therapeutics
Halozyme
Horizon Therapeutics
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JPM Day 1: Highlights
JPM Day 1: Highlights
BioSpace
JPMHC 2023
Sarepta Therapeutics
Biomarin
Alnylam
JNJ
Arrowhead Pharmaceuticals
Novartis
Bristol Myers Squibb
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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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Sarepta-partnered Hansa touts new phase 2 data of one-trick pony immunological treatment
Sarepta-partnered Hansa touts new phase 2 data of one-trick pony immunological treatment
Fierce Biotech
Hansa Biopharma
clinical trials
imlifidase
transplants
Sarepta Therapeutics
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FDA grants speedy review to Sarepta’s Duchenne gene therapy
FDA grants speedy review to Sarepta’s Duchenne gene therapy
BioPharma Dive
Sarepta Therapeutics
SRP-9001
FDA
Duchenne Muscular Dystrophy
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FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial
FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial
Endpoints
Sarepta Therapeutics
generics
Duchenne Muscular Dystrophy
FDA
eteplirsen
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