Monthly Prescribing Reference

FDA Fast Tracks Phentolamine Eyedrop to Improve Night Vision After Keratorefractive Surgery

The Fast Track designation is supported by the ongoing randomized, double-masked phase 3 LYNX-2 trial. The Food and Drug Administration (FDA) has granted Fast Track designation to phentolamine ...
Business Wire

Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery

MINNEAPOLIS--(BUSINESS WIRE)--Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that the U.S. Food & Drug Administration (FDA) has granted ...
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 ...
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, ...