In this news episode of Trending Health, Mindy McGrath and Everly Petruzzelli break down the evolving regulatory landscape at the FDA and what it means for life sciences leaders. This episode covers:

• Staff changes to the FDA and approval pathway pilot programs
• Rising scrutiny on trial design — especially in rare disease
• The FDA’s firmer stance on compounded GLP-1s as shortages ease 

From regulatory unpredictability to access, pricing, and portfolio risk, we explore how life sciences leaders should adapt in a more dynamic regulatory environment. 

For additional discussion and to see the sources referenced in this episode, check out TrendingHealth.com. 

Panel – Mindy McGrath & Everly Petruzzelli 

Recording & Editing – Mike Liberto & Rachel Skonecki  

Source Links: 

• J&J\’s Tecvayli-Darzalex multiple myeloma combo takes home FDA\’s 3rd national priority nod  
• FDA slammed over rare disease drug decisions 
• Disc\’s rare disease drug hit by FDA rejection 
• FDA rejects Biohaven approval request for troriluzole, triggering cost cutting 
• FDA reverses course, agrees to review Moderna’s flu vaccine 
• FDA ramps up crackdown on GLP-1 drug compounding with fresh batch of 30 warning letters