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 ...

Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Detailed price information for Oncolytics Biotech Inc (ONCY-Q) from The Globe and Mail including charting and trades.
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, ...