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#366DiasdeEERR La@FDAenEspanol ha aprobado un tratamiento para un tipo de la distrofia muscular#DM de#Duchenne, el fármaco#golodirsen q se une a otros ttos. q ha investigado@Sarepta para#Duchenne#musculardystophy Gracias,#ThankYou Cc@DPPSpain https://genotipia.com/genetica_medica_news/golodirsen-distrofia-muscular-de-duchenne/ …pic.twitter.com/qSxNRTKGwO
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FDA rejection letters typically stay private. Correspondence between the agency and
@Sarepta shed light on the thinking that led to the rejection and subsequent approval of Duchenne muscular dystrophy drug#golodirsen https://xconomy.com/boston/2020/01/22/fda-flags-risk-of-infection-kidney-damage-for-sarepta-duchenne-drugs/ …$SRPT -
This letter from
#FDA's#Unger to#Sarepta, detailing his unease with#golodirsen, is scathing. Apart from the scant evidence of#efficacy, he highlights tox profile of eteplirsen, saying it taints golodirsen's risk-benefit profile. Still confused, why was it approved?$SRPThttps://twitter.com/RxRegA/status/1219930729666220032 …
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The U.S. Food and Drug Administration has approved Vyondys 53
#golodirsen to treat patients with Duchenne muscular dystrophy#DMD amenable to exon 53 skipping.@US_FDA@Sarepta@US_FDA Sarepta Therapeuticshttps://checkrare.com/fda-approves-second-exon-skipping-drug-for-duchenne/ … -
FDA approves
#golodirsen injection, the first treatment for Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping. http://ms.spr.ly/6014Tn3un pic.twitter.com/e7Ka0sEtIR
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Surprisingly,
@US_FDA grants @Sarepta ‘s#golodirsen accelerated approval for#DMD todayhttps://www.benzinga.com/node/14984755Prikaži ovu nit -
$SRPT it's about time FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation accelerated approval to Vyondys 53#golodirsen https://www.prnewswire.com/news-releases/fda-grants-accelerated-approval-to-first-targeted-treatment-for-rare-duchenne-muscular-dystrophy-mutation-300974396.html … -
The
@fda is failing us, allowing poisons and carcinogens in the generic medicine that many of us take, yet cannot approve a drug for a disease that has no current treatment.@ellisunger#golodirsen$srpt -
Attending
@Sarepta symposium at#Myology2019 Perry Shieh gives an overview to exon skipping drugs for DMD#eteplirsen#golodirsen#casimersenpic.twitter.com/2Wmh5LvUKX
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Pleased to hear that
@Sarepta has filed an application with@US_FDA seeking approval of#Duchenne drug#golodirsen. Find out more: http://qoo.ly/uh3u5 pic.twitter.com/uQ81y0BZhl
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$SRPT#Golodirsen will be approved by Aug/2019, followed by#Casimersen EX-45 1Q-2020 so we are looking for ~$1B revenue from PMO by 2021 Applying X8 for 2020-revenue we get a discounted Mcap & FREE#GeneTherapy pipeline The market will realize the numbers sooner than laterhttps://twitter.com/GantosJ/status/1075746116602220544 … -
While
$PFE terminating#DMD study not meeting primary endpoint,$SRPT had#Exondys51 approved &#Golodirsen in rolling submission for AA &#Casimersen will get FDA acceptance AA as well by YE, & on the top microD#GeneTherapy study showing amazing results.$SRPT owns DMD Markethttps://twitter.com/GantosJ/status/1035136796282290176 … -
Vantage Snippet - Nippon Shinyaku takes on Sarepta but patent questions remain
#DMD$NPPNY$SRPT#golodirsen pic.twitter.com/fcJJmrjxmo
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NT REWIND:
#Golodirsen boosts#dystrophin in patients with#Duchenne muscular dystrophy. Is the drug an effective therapy? Read here. http://bit.ly/2sSNffW pic.twitter.com/UqyzoGofgn
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Attending
#AAN18? Perry Shieh, MD, PhD will be discussing#golodirsen data on exon skipping and sarcolemmal#dystrophin expression in patients with genetic mutations amenable to exon 53 skipping at 1PM PDT in Theatre 411. SRPT -
Sarepta Therapeutics announces plan to submit a new drug application (NDA) for accelerated approval of
#Golodirsen (SRP-4053) in patients with#Duchenne muscular dystrophy amenable to skipping exon 53 http://bit.ly/2p5aMs6@Sareptapic.twitter.com/BI3mNH1EAw
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.
@Sarepta intends to file for@US_FDA approval for exon 53#Duchenne drug#golodirsen http://qoo.ly/mwyzf pic.twitter.com/Wu6VG3T2QJ
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$SRPT met with the FDA to seek guidance on the possibility of filing NDA this year and to seek an accelerated approval for#GOLODIRSEN If the FDA give GREEN LIGHT to file, SRPT will file NDA under AA during 2018 & approval in 2019 this will save 2years instead waiting for ESSENCEPrikaži ovu nit -
$SRPT#golodirsen poster: most impressive to me is immuno-histo Figure8 Makes me want to believe in clinical value. http://investorrelations.sarepta.com/static-files/64d8d897-2e4a-4119-80b4-115cbae17993 …pic.twitter.com/K1SfIRPBZR
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