New FDA Approvals

Capivasertib for Breast Cancer, Repotrectinib for NSCLC, Enzalutamide for Prostate Cancer, Pembrolizumab for Stomach Cancer, Hypertension Device


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  • Implementing AMA Style – 8 Things to Get Right in Your Next Project
  • Needs Assessments – 7 Essentials for Getting Funded
  • Working With Your Medical Writer – 8 Ways to Get the Most out of Them

See the full write ups for today's episode at nascentmc.com/podcast

 

Here are the highlights:

·       Capivasertib (Truqap) has been FDA-approved for the treatment of hormone receptor-positive/HER2-negative breast cancer with AKT pathway alterations, showing improved progression-free survival in clinical trials.

·       Repotrectinib (Augtyro) has received FDA approval for ROS1-positive non-small cell lung cancer (NSCLC), demonstrating high response rates in patients who had not received a prior tyrosine kinase inhibitor.

·       Enzalutamide (Xtandi) has gained FDA approval for nonmetastatic castration-sensitive prostate cancer (nmCSPC) in high-risk patients with biochemical recurrence, expanding its use in prostate cancer treatment.

·       Pembrolizumab (Keytruda) has received supplemental approval for the first-line treatment of HER2-negative stomach cancer when combined with chemotherapy, showing improved overall survival compared to chemotherapy alone.

·       The Symplicity Spyral™ renal denervation (RDN) system has been approved by the FDA for treating hypertension through a minimally invasive procedure targeting overactive nerves near the kidneys. 

·       A combination of taurolidine and heparin catheter lock solution (DefenCath) has been approved for preventing catheter-related bloodstream infections in hemodialysis patients, demonstrating a significant reduction in infection risk in clinical trials.

 

 

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Garden Of Love by Pk jazz Collective

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New FDA ApprovalsBy Emma Hitt Nichols, PhD

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