Business Insider

FDA Grants Fast Track Status to Amplyx Pharmaceuticals for IV and Oral Formulations of Fosmanogepix (APX001) for Seven Different Indications

SAN DIEGO, Sept. 9, 2019 /PRNewswire/ -- Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with ...
Nasdaq

Polaryx Therapeutics Receives U.S. FDA Fast Track Designations for All Four Indications to be Evaluated in the SOTERIA Basket Trial

PARAMUS, N.J., April 21, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric LSDs, ...
Nasdaq

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial ...

The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, ...
Monthly Prescribing Reference

Novel Antifungal Gains Fast Track Designation for Seven Indications

The Food and Drug Administration (FDA) has granted Fast Track designations to both the oral and intravenous formulations of fosmanogepix (APX001; Amplyx Pharmaceuticals) for 7 antifungal indications, ...
Monthly Prescribing Reference

Luspatercept Fast Tracked for Two Beta-Thalassemia Indications

Celgene and Acceleron announced that the Food and Drug Administration (FDA) has granted Fast Track designations to luspatercept for use in two separate indications: for the treatment of patients with ...