FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The FDA's recent decision to add a strong warning to Sarepta's gene therapy highlights ongoing concerns about patient safety in medical treatments. This follows a pattern seen in other health-related issues, such as the recall of ByHeart infant formula due to botulism risks, which also involved FDA warnings. Additionally, similar concerns were raised regarding a heart device that led to increased patient deaths, suggesting a broader issue of accountability in healthcare practices. These incidents underline the critical need for rigorous oversight and transparency in the approval processes for medical therapies.