FDA’s Conditional Approval Plan Would Unleash Biotech Innovation

In a move that could dramatically reshape the landscape for rare disease treatments, FDA Commissioner Marty Makary has announced plans to create a new pathway for drugs targeting rare conditions. This announcement signals a potential paradigm shift in how the FDA approaches drug approvals for conditions affecting small patient populations—a change that many experts believe is long overdue. “We’re going to be rolling out a new pathway for drugs, which…