FDA Grants Fast Track Designation to Merakris’ MTX-001, Opening Potential Accelerated Path to Market for Venous Leg Ulcer Therapy

MTX-001 is an investigational biologic therapy being developed to address underlying biological deficiencies associated with impaired wound healing. The therapy is designed to deliver a concentrated ...
The Manila Times

Nouscom Receives U.S. FDA Fast Track Designation for NOUS-209, a Novel Immunotherapy for the Prevention of Lynch Syndrome-Associated Cancers

Fast Track Designation (FTD) recognizes NOUS-209’s potential to address a serious condition with significant unmet medical need in Lynch Syndrome (LS) carriersNOUS-209 is an off-the-shelf cancer ...
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, ...