BioCentury This Week cover image

Ep. 317 - Biotech IPOs, FDA-Stealth & Patent Threat

BioCentury This Week

00:00

Navigating FDA Approval for Barth Syndrome Treatment

This chapter explores the intricate journey of a biopharmaceutical company working towards FDA approval for a drug targeting Barth syndrome, detailing the challenges faced throughout the process. It highlights key moments, including the mixed vote from an advisory committee and the influence of patient advocacy efforts on expedited approval discussions. Additionally, the chapter examines broader themes in the biotech industry, such as the impact of regulatory environments and international influences on drug development.

Transcript
Play full episode

The AI-powered Podcast Player

Save insights by tapping your headphones, chat with episodes, discover the best highlights - and more!
App store bannerPlay store banner
Get the app