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» Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
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
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
Chasing Pfizer and Roche, Regenxbio benefits from FDA boost for DMD gene therapy
Fierce Biotech
Tue, 04/11/23 - 11:32 am
Regenxbio
adeno-associated viruses
Duchenne Muscular Dystrophy
FDA
5 FDA decisions to watch in the second quarter
BioPharma Dive
Mon, 04/3/23 - 11:06 pm
FDA
Sarepta Therapeutics
Duchenne Muscular Dystrophy
Biogen
tofersen
ALS
Seres Therapeutics
C. difficile
Pfizer
GSK
vaccines
RSV
Regeneron
Eylea
Vertex flexes its dealmaking muscle
EP Vantage
Mon, 03/27/23 - 10:07 am
Vertex Pharmaceuticals
Entrada Therapeutics
Tevard Biosciences
Duchenne Muscular Dystrophy
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
Vertex tiptoes further into Duchenne research with Tevard deal
BioPharma Dive
Tue, 02/28/23 - 10:37 pm
Vertex Pharmaceuticals
Duchenne Muscular Dystrophy
DMD
Tevard Biosciences
Duchenne muscular dystrophy’s progress so far in 2023
Clinical Trials Arena
Wed, 02/22/23 - 10:00 am
Duchenne Muscular Dystrophy
DMD
Santhera Pharmaceuticals
ReveraGen
vamorolone
Regenxbio
RGX-202
FDA accepts Santhera, ReveraGen’s vamorolone NDA to treat DMD
Pharmaceutical Business Review
Tue, 01/10/23 - 10:42 am
Santhera Pharmaceuticals
ReveraGen
vamorolone
Duchenne Muscular Dystrophy
FDA
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
Fresh from Vertex payday, Entrada's DMD plans are derailed by FDA hold
Fierce Biotech
Tue, 12/20/22 - 10:42 am
Entrada Therapeutics
Vertex Pharmaceuticals
FDA
clinical trials
Duchenne Muscular Dystrophy
myotonic muscular dystrophy
ENTR-601-44
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
Only Patient in N-of-1 CRISPR Trial for Duchenne Muscular Dystrophy Dies
BioSpace
Mon, 11/7/22 - 10:45 am
CRISPR
clinical trials
patient deaths
Duchenne Muscular Dystrophy
CRD-TMH-001
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