In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 10, 2023 – July 14, 2023.  Please check back every Monday morning so that you can stay up to date.  

Get our free download! Implementing AMA Style – 8 Things to Get Right  Here are the highlights of this week's episode:

• Opill® is the first over-the-counter birth control pill approved by the FDA, containing norgestrel tablets as a progestin-only contraceptive. Opill® thickens cervical mucus, prevents the release of eggs, and thins the uterine lining to provide effective contraception. Opill® will be available in stores in the US in early 2024
• Leqvio® (inclisiran) has received FDA approval for expanded use in patients with elevated LDL-C and increased risk of heart disease, in addition to its previous indications. The drug is an RNA therapy that lowers LDL-C levels and is administered via a single subcutaneous injection initially, followed by repeat doses every 3 and 6 months. Clinical studies showed a mean reduction of approximately 50% in LDL-C levels; common adverse reactions are injection site reactions, arthralgia, and bronchitis.
• Takeda has withdrawn its Biologics License Application for the Dengue vaccine candidate, TAK-003, following FDA's request for additional data not included in the application. TAK-003, also known as Qdenga®, is already approved in various countries. Dengue is a mosquito-borne disease causing significant illness and deaths worldwide; currently, there are limited vaccines or other preventive agents available.

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 nascentmc.com

Intro and outro music

Garden Of Love by Pk jazz Collective