News Medical

The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
Seeking Alpha

Greenwich LifeSciences: Fast Track Designation Does Not Solve Fundamental Issues

Greenwich LifeSciences focuses on developing GLSI-100, a HER2-positive breast cancer vaccine, recently granted FDA Fast Track designation. GLSI's Fast Track status offers regulatory advantages but ...
Nasdaq

Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 in Myotonic Dystrophy Type 1, Anticipates U.S. Accelerated Approval Submission in H1 2026

Dyne Therapeutics announces FDA Fast Track designation for DYNE-101, targeting myotonic dystrophy type 1 with potential accelerated approval in 2026. Dyne Therapeutics has announced that its ...
Nasdaq

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, ...