Rezultati pretraživanja
  1. 12. kol 2019.

    Gilead deal shocked investors. Can we see the uptrend continue?

  2. 10. svi 2017.

    Durect and Sandoz sign $293m deal to commercialise Posimir in US

  3. 25. pro 2019.

    Advisory Committee meeting scheduled for January 16, 2020, will result in PDUFA date extension from 12/27/19 original schedule.

  4. 17. sij

    DURECT Corporation Announces Outcome of FDA Advisory Committee Meeting for ®

  5. 18. sij

    FDA rejects 2 new with overwhelming majority vote. But panel was split over ( / ) combo and new long-acting

  6. 20. lis 2017.
  7. 16. sij

    The committee is now on break until 2:30 pm US ET and will return to Q4 (approval vote).

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  8. 16. sij

    FDA ADCOMM VOTE: Has the Applicant submitted adequate efficacy and safety data to support approval of , bupivacaine extended-release solution, for indication of single-dose instillation into the surgical site to produce post-surgical analgesia? 6-Y 6-N 0-Abstain

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  9. 16. sij

    This week's FDA Adcomm tally: 2 ties, 2 down votes Ties for Durect's (bupivacaine depot) (6-6) + Esteve's tramadol/celecoxib (13-13) Down votes for Nektar's (27-0) + Intellipharmaceutics' (proposed abuse-deterrent oxycodone) (24-2)

  10. 22. lip 2017.

    HSMN: Completes Enrollment in PERSIST, Phase 3 trial for

  11. 9. svi 2017.
  12. "We continue to expect a positive outcome from 's pivotal study for ."-Ram Selvaraju

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