New FDA Approvals

Prostate Cancer Combo Pill, Multiple Myeloma BiTE, Geographic Atrophy, POLARx for AFib


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

In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 7, 2023 – August  11, 2023.  Please check back every Monday morning so that you can stay up to date.

 Here are the highlights:

·      The FDA has approved Akeega, a combination of niraparib (PARP inhibitor) and abiraterone acetate (anti-androgen), as the first orally administered treatment for BRCA-positive metastatic castration-resistant prostate cancer. The approval was based on the MAGNITUDE study showing improved progression-free survival with the addition of niraparib.

·      Talvey (talquetamab-tgvs), a bispecific T-cell engaging antibody, has received accelerated approval for patients with relapsed or refractory multiple myeloma who have undergone multiple previous therapies.

·      Izervay (avacincaptad pegol intravitreal solution), a complement C5 inhibitor, has gained FDA approval for use in geographic atrophy related to age-related macular degeneration, and showed a significant reduction in disease progression.

·      Boston Scientific's POLARx Cryoablation System has been approved for treating paroxysmal atrial fibrillation, demonstrating effectiveness in reducing paroxysmal atrial arrhythmias in the FROZEN-AF IDE clinical trial.

 The full writeups are available here: https://nascentmc.com/podcast/

Intro and outro music

Garden Of Love by Pk jazz Collective

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New FDA ApprovalsBy Emma Hitt Nichols, PhD

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