Go offline with the Player FM app!
Vanflyta®, Beyfortus™, Cyfendus™, Ycanth™
Manage episode 407556914 series 3561458
In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 17, 2023 – July 21, 2023. Please check back every Monday morning so that you can stay up to date.
Here are the highlights:
- Vanflyta® for FLT3-ITD+ AML The FDA has approved Vanflyta (quizartinib), developed by Daiichi Sankyo, for treating adult patients with acute myeloid leukemia (AML) having the FLT3-ITD mutation. The approval came after data from the QuANTUM-First trial showed improved overall survival rates when Vanflyta was added to treatment. This makes Vanflyta the third drug approved for FLT3-positive AML, joining Novartis' Rydapt® and Astellas Pharma's Xospata®.
- BeyfortusTM for RSV AstraZeneca's BeyfortusTM (nirsevimab) has been approved by the FDA for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants, and children up to 24 months of age. The approval was supported by data from three clinical trials, and the drug has also been given a fast-track designation. Beyfortus becomes the second antibody available for RSV protection in young children, following palivizumab or Synagis®.
- Cyfendus Anthrax Vaccine The FDA has approved CyfendusTM (Anthrax Vaccine Adsorbed, Adjuvanted) for post-exposure prophylaxis following exposure to Bacillus anthracis, the bacterium causing Anthrax, in adults aged 18 to 65. The vaccine is administered in two doses, two weeks apart, and clinical trials have found it to be non-inferior to the already available BioThrax® vaccine. Cyfendus has been in use since 2019 under a pre-emergency use authorization.
- YcanthTM for Molluscum Contagiosum The FDA has approved Verrica Pharmaceuticals' YcanthTM (cantharidin) topical solution for treating molluscum contagiosum in patients aged 2 and older. The approval is based on results from two identical phase 3 trials involving over 500 patients. Despite being available via compounding sources for years, Ycanth is the first FDA-approved standardized product for molluscum contagiosum.
This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit Nascent Medical.
Intro and outro music
60 episodes
Manage episode 407556914 series 3561458
In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 17, 2023 – July 21, 2023. Please check back every Monday morning so that you can stay up to date.
Here are the highlights:
- Vanflyta® for FLT3-ITD+ AML The FDA has approved Vanflyta (quizartinib), developed by Daiichi Sankyo, for treating adult patients with acute myeloid leukemia (AML) having the FLT3-ITD mutation. The approval came after data from the QuANTUM-First trial showed improved overall survival rates when Vanflyta was added to treatment. This makes Vanflyta the third drug approved for FLT3-positive AML, joining Novartis' Rydapt® and Astellas Pharma's Xospata®.
- BeyfortusTM for RSV AstraZeneca's BeyfortusTM (nirsevimab) has been approved by the FDA for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants, and children up to 24 months of age. The approval was supported by data from three clinical trials, and the drug has also been given a fast-track designation. Beyfortus becomes the second antibody available for RSV protection in young children, following palivizumab or Synagis®.
- Cyfendus Anthrax Vaccine The FDA has approved CyfendusTM (Anthrax Vaccine Adsorbed, Adjuvanted) for post-exposure prophylaxis following exposure to Bacillus anthracis, the bacterium causing Anthrax, in adults aged 18 to 65. The vaccine is administered in two doses, two weeks apart, and clinical trials have found it to be non-inferior to the already available BioThrax® vaccine. Cyfendus has been in use since 2019 under a pre-emergency use authorization.
- YcanthTM for Molluscum Contagiosum The FDA has approved Verrica Pharmaceuticals' YcanthTM (cantharidin) topical solution for treating molluscum contagiosum in patients aged 2 and older. The approval is based on results from two identical phase 3 trials involving over 500 patients. Despite being available via compounding sources for years, Ycanth is the first FDA-approved standardized product for molluscum contagiosum.
This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit Nascent Medical.
Intro and outro music
60 episodes
All episodes
×Welcome to Player FM!
Player FM is scanning the web for high-quality podcasts for you to enjoy right now. It's the best podcast app and works on Android, iPhone, and the web. Signup to sync subscriptions across devices.