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» Sarepta Therapeutics
Sarepta Therapeutics
FDA delays decision on Duchenne gene therapy and considers narrower approval
BioPharma Dive
Wed, 05/24/23 - 11:21 am
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
Sarepta Enters Uncharted Territory with Adcomm Approval
BioSpace
Mon, 05/22/23 - 10:22 am
Sarepta Therapeutics
SRP-9001
DMD
Duchenne Muscular Dystrophy
FDA
gene therapy
FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy
Fierce Biotech
Mon, 05/15/23 - 11:18 am
Sarepta Therapeutics
FDA
DMD
gene therapy
Duchenne Muscular Dystrophy
2023’s biggest launches: the story so far
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Fri, 05/12/23 - 10:19 am
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FDA reviewers flag concerns over Sarepta's gene therapy for DMD
Yahoo/Reuters
Wed, 05/10/23 - 10:08 am
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm
Fierce Biotech
Wed, 05/3/23 - 11:39 am
Sarepta Therapeutics
FDA
SRP-9001
DMD
Duchenne Muscular Dystrophy
Go or no go? Sarepta’s gene therapy faces scrutiny
EP Vantage
Thu, 04/27/23 - 10:29 am
Sarepta Therapeutics
gene therapy
SRP-9001
Roche
DMD
Duchenne Muscular Dystrophy
Sarepta shares drop as report says FDA almost rejected under-review gene therapy
Yahoo/Reuters
Fri, 04/14/23 - 10:16 am
Sarepta Therapeutics
FDA
gene therapy
DMD
Duchenne Muscular Dystrophy
5 FDA decisions to watch in the second quarter
BioPharma Dive
Mon, 04/3/23 - 11:06 pm
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Duchenne Muscular Dystrophy
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FDA Reverses Course; Will Hold Adcomm for Sarepta’s DMD Gene Therapy
BioSpace
Fri, 03/17/23 - 10:13 am
FDA
Sarepta Therapeutics
DMD
gene therapy
Duchenne Muscular Dystrophy
SRP-9001
Duchenne muscular dystrophy: major trials and events to watch in 2023
Clinical Trials Arena
Thu, 03/16/23 - 09:49 am
DMD
Duchenne Muscular Dystrophy
clinical trials
gene therapy
FDA
Sarepta Therapeutics
SRP-9001
FibroGen
pamrevlumab
Capricor
CAP-1002
Santhera
ReveraGen
vamorolone
Sarepta: FDA finds ‘no significant safety issues of concern’ with DMD gene therapy
Biopharma Reporter
Mon, 03/6/23 - 11:29 pm
Sarepta Therapeutics
DMD
Duchenne Muscular Dystrophy
gene therapy
FDA
Sarepta's DMD gene therapy inches closer to market as FDA declines to hold advisory meeting
Fierce Biotech
Wed, 03/1/23 - 09:52 am
FDA
Sarepta Therapeutics
SRP-9001
gene therapy
DMD
Duchenne Muscular Dystrophy
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EP Vantage
Wed, 01/18/23 - 09:46 am
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Mon, 01/9/23 - 11:01 pm
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Sarepta marches forward with its potential DMD gene therapy and an expanded Catalent manufacturing deal
Endpoints
Thu, 01/5/23 - 04:58 pm
Sarepta Therapeutics
SRP-9001
gene therapy
Duchenne Muscular Dystrophy
CDMOs
Catalent
Sarepta-partnered Hansa touts new phase 2 data of one-trick pony immunological treatment
Fierce Biotech
Tue, 11/29/22 - 11:10 am
Hansa Biopharma
clinical trials
imlifidase
transplants
Sarepta Therapeutics
FDA grants speedy review to Sarepta’s Duchenne gene therapy
BioPharma Dive
Tue, 11/29/22 - 10:50 am
Sarepta Therapeutics
SRP-9001
FDA
Duchenne Muscular Dystrophy
FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial
Endpoints
Sat, 11/26/22 - 07:15 pm
Sarepta Therapeutics
generics
Duchenne Muscular Dystrophy
FDA
eteplirsen
Sarepta preps $1.2B war chest as DMD gene therapy nears accelerated FDA nod
Fierce Biotech
Thu, 11/3/22 - 11:56 am
Sarepta Therapeutics
Duchenne Muscular Dystrophy
SRP-9001
gene therapy
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