Health ❯ Regulatory Affairs

FDA Approval Process

Drug Safety Drug Approval Accelerated Approval Clinical Development Drug Applications

Structure’s Oral Obesity Pill Delivers 16.3% Placebo-Adjusted Weight Loss in Phase 2

The company set an FDA end-of-Phase-2 meeting for Q2 2026 ahead of a planned Phase 3 start in the second half of the year.

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

Sarepta Shares Plunge After ESSENCE Phase 3 Miss in Duchenne Trial