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Вміст надано Emma Nichols, PhD and Emma Hitt Nichols. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Emma Nichols, PhD and Emma Hitt Nichols або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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Ingrezza Sprinkles for Huntington’s, Tivdak for Cervical Cancer, Xolremdi for WHIM, Esprit Stent for CLTI-BTK

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Manage episode 417002626 series 3561458
Вміст надано Emma Nichols, PhD and Emma Hitt Nichols. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Emma Nichols, PhD and Emma Hitt Nichols або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.

Please visit Nascentmc.com for medical writing assistance for your company. Visit learnAMAstyle.com for free downloads on medical writing and editing Ingrezza for Huntington’s:

  • The FDA has approved valbenazine (INGREZZA® SPRINKLE) capsules for adults with tardive dyskinesia and chorea associated with Huntington's disease.
  • This new oral granules formulation provides an alternative for those with swallowing difficulties, maintaining the same dosage strengths as the original capsule form.
  • Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor designed to reduce uncontrollable movements by inhibiting dopamine release.

Tivdak for Cervical Cancer:

  • Tisotumab vedotin-tftv (TIVDAK) has been approved for recurrent or metastatic cervical cancer after chemotherapy failure.
  • This approval was based on results from a Phase 3 trial showing a significant overall survival benefit compared to chemotherapy.
  • The approval highlights a significant advancement in treating this aggressive form of cancer, granted to Pfizer and Genmab A/S.

Xolremdi for WHIM:

  • Mavorixafor (Xolremdi) has been approved for WHIM syndrome in patients 12 years and older to increase circulating neutrophils and lymphocytes.
  • WHIM syndrome is a rare genetic disorder impairing immune function, and mavorixafor significantly improves cell counts and reduces infection risk.
  • Approval was based on positive results from a double-blind trial and granted to X4 Pharmaceuticals.

Esprit Stent for CLTI-BTK:

  • The FDA has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System for chronic limb-threatening ischemia below-the-knee.
  • This is the first approval of its kind in the U.S., offering an alternative to traditional balloon angioplasty.
  • The approval was based on positive outcomes from the LIFE-BTK trial, showing significant disease progression reduction compared to standard care, granted to Abbott Laboratories.

  continue reading

53 епізодів

Artwork
iconПоширити
 
Manage episode 417002626 series 3561458
Вміст надано Emma Nichols, PhD and Emma Hitt Nichols. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Emma Nichols, PhD and Emma Hitt Nichols або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.

Please visit Nascentmc.com for medical writing assistance for your company. Visit learnAMAstyle.com for free downloads on medical writing and editing Ingrezza for Huntington’s:

  • The FDA has approved valbenazine (INGREZZA® SPRINKLE) capsules for adults with tardive dyskinesia and chorea associated with Huntington's disease.
  • This new oral granules formulation provides an alternative for those with swallowing difficulties, maintaining the same dosage strengths as the original capsule form.
  • Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor designed to reduce uncontrollable movements by inhibiting dopamine release.

Tivdak for Cervical Cancer:

  • Tisotumab vedotin-tftv (TIVDAK) has been approved for recurrent or metastatic cervical cancer after chemotherapy failure.
  • This approval was based on results from a Phase 3 trial showing a significant overall survival benefit compared to chemotherapy.
  • The approval highlights a significant advancement in treating this aggressive form of cancer, granted to Pfizer and Genmab A/S.

Xolremdi for WHIM:

  • Mavorixafor (Xolremdi) has been approved for WHIM syndrome in patients 12 years and older to increase circulating neutrophils and lymphocytes.
  • WHIM syndrome is a rare genetic disorder impairing immune function, and mavorixafor significantly improves cell counts and reduces infection risk.
  • Approval was based on positive results from a double-blind trial and granted to X4 Pharmaceuticals.

Esprit Stent for CLTI-BTK:

  • The FDA has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System for chronic limb-threatening ischemia below-the-knee.
  • This is the first approval of its kind in the U.S., offering an alternative to traditional balloon angioplasty.
  • The approval was based on positive outcomes from the LIFE-BTK trial, showing significant disease progression reduction compared to standard care, granted to Abbott Laboratories.

  continue reading

53 епізодів

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