The Basket Trial Is the New Black — and the FDA Hasn’t Caught Up
Arrowhead Pharmaceuticals' Phase 1 basket trial of zodasiran enrolled five distinct lipid disorder populations under a single protocol —...
FDA Guidance
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...
The $30 Million Bet: CNS Investors Are Back — and Registrational Trial Design Hasn’t Kept Up
Serina Therapeutics just closed a $30 million private placement at a 68% premium to fund a registrational trial for...
How Practical Is FDA’s HCP Approach in DCTs?
The FDA’s latest guidance on Decentralized Clinical Trials (DCTs) marks a pivotal shift in the clinical research landscape. This...
FDA Unveils Groundbreaking Rare Disease Guidance Document
In a landmark move, the U.S. Food and Drug Administration (FDA) has released a detailed guidance document titled “Rare...