Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection; HBeAg- cohort sample size increased to optimize powering; fu ...
・The company said that the designation is supported by clinical data which demonstrates a 33% objective response rate for pelareorep-based therapy. ・According to Oncolytics, there are an estimated 2 ...
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 ...
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, ...