Recent FDA Approvals

First-in-Class First drug with a novel mechanism of action for a given disease. Often opens an entirely new therapeutic category.

Orphan Drug Targets a rare disease affecting fewer than 200,000 people in the US. Sponsor receives 7-year market exclusivity, tax credits, and PDUFA fee waivers.

Breakthrough Granted when preliminary clinical evidence suggests substantial improvement over existing therapies on a clinically significant endpoint. Comes with intensive FDA guidance.

Accelerated Approval based on a surrogate endpoint reasonably likely to predict clinical benefit. Sponsor must complete confirmatory trials post-approval.

Priority Review FDA reviews within 6 months instead of the standard 10, reserved for drugs offering significant improvements in safety or effectiveness.

Fast Track Enables more frequent FDA meetings, rolling review, and Priority Review eligibility for drugs filling unmet medical needs.