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Prostate Cancer Combo Pill, Multiple Myeloma BiTE, Geographic Atrophy, POLARx for AFib
Manage episode 407556911 series 3561458
Check out our free downloads at nascentmc.com:
- 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 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
60 episodios
Manage episode 407556911 series 3561458
Check out our free downloads at nascentmc.com:
- 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 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
60 episodios
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