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Aducanumab's Big Day Arrives, But How Much Will US FDA Panel Vote Matter?

 
• By Brenda Sandburg and Sue Sutter

Agency thinks Biogen’s sucessful Phase III study supports approval, but given the negative outcome of another trial and disease-modifying mechansim of action, an advisory committee endorsement could go a long way in assuring the public the Alzheimer's drug actually works; the panel will comprise 11 voting members, four of whom were added as temporary members for their expertise in neurology, biostatistics and patient advocacy.

Concept of memory loss and brain aging due to dementia and Alzheimer's disease as a medical icon with fall trees shaped as a human head losing leaves
Biogen's Alzheimer's disease drug aducanumab is facing an FDA advisory committee review • Source: Shutterstock

The US Food and Drug Administration’s positive view of Biogen, Inc.’s aducanumab suggests the agency may be primed to approve the Alzheimer’s drug with or without the backing of its external experts.

However, given thediscordant data from two Phase III trials that were prematurely terminated, and the agency's work with Biogen in...

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US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
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Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.