Rezultati pretraživanja
  1. 28. sij

    La ha aprobado un tratamiento para un tipo de la distrofia muscular de , el fármaco q se une a otros ttos. q ha investigado para Gracias, Cc

  2. 23. sij

    FDA rejection letters typically stay private. Correspondence between the agency and shed light on the thinking that led to the rejection and subsequent approval of Duchenne muscular dystrophy drug

  3. 22. sij

    This letter from 's to , detailing his unease with , is scathing. Apart from the scant evidence of , he highlights tox profile of eteplirsen, saying it taints golodirsen's risk-benefit profile. Still confused, why was it approved?

  4. 18. pro 2019.

    The U.S. Food and Drug Administration has approved Vyondys 53 to treat patients with Duchenne muscular dystrophy amenable to exon 53 skipping. Sarepta Therapeutics

  5. 14. pro 2019.

    FDA approves injection, the first treatment for Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping.

  6. 12. pro 2019.

    ⁦Surprisingly, ⁩ grants ⁦⁩ ‘s accelerated approval for today

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  7. 12. pro 2019.

    it's about time FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation accelerated approval to Vyondys 53

  8. 12. ruj 2019.

    The 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.

  9. 26. ožu 2019.

    Attending symposium at Perry Shieh gives an overview to exon skipping drugs for DMD

  10. Pleased to hear that has filed an application with seeking approval of drug . Find out more:

    exon skipping.jpg
  11. 20. pro 2018.

    will be approved by Aug/2019, followed by 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 pipeline The market will realize the numbers sooner than later

  12. 30. kol 2018.

    While terminating study not meeting primary endpoint, had approved & in rolling submission for AA & will get FDA acceptance AA as well by YE, & on the top microD study showing amazing results. owns DMD Market

  13. 28. lip 2018.

    Vantage Snippet - Nippon Shinyaku takes on Sarepta but patent questions remain

  14. 13. lip 2018.

    NT REWIND: boosts in patients with muscular dystrophy. Is the drug an effective therapy? Read here.

  15. 24. tra 2018.

    Attending ? Perry Shieh, MD, PhD will be discussing data on exon skipping and sarcolemmal expression in patients with genetic mutations amenable to exon 53 skipping at 1PM PDT in Theatre 411. SRPT

  16. 12. ožu 2018.

    Sarepta Therapeutics announces plan to submit a new drug application (NDA) for accelerated approval of (SRP-4053) in patients with muscular dystrophy amenable to skipping exon 53

  17. 10. ožu 2018.

    met with the FDA to seek guidance on the possibility of filing NDA this year and to seek an accelerated approval for 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 ESSENCE

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  18. 9. lis 2017.
  19. 8. lis 2017.

    poster: most impressive to me is immuno-histo Figure8 Makes me want to believe in clinical value.

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