Tag Archives: FDA Fast Track

Efdoralprin Alfa Meets All Endpoints in Sanofi’s Phase 2 Study, Paving Way for First Recombinant Therapy in AATD

(IN BRIEF) Sanofi’s investigational therapy efdoralprin alfa met all primary and key secondary endpoints in the Phase 2 ElevAATe study for alpha-1 antitrypsin deficiency emphysema, demonstrating superior efficacy compared to standard plasma-derived therapy. The results highlight its potential as the … Read the full press release

Basilea Launches FORWARD‑IM Phase 3 Trial of Fosmanogepix in Invasive Mold Infections

(IN BRIEF) Basilea Pharmaceutica has initiated FORWARD‑IM, a global Phase 3 trial evaluating fosmanogepix in adults with invasive mold infections. Building on positive Phase 1 and Phase 2 results—and following the FAST‑IC Phase 3 candidemia trial—this open‑label study will randomize about 160 patients to … Read the full press release

GSK’s Bepirovirsen Receives FDA Fast Track Designation for Chronic Hepatitis B Treatment

(IN BRIEF) GSK plc has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) targeting chronic hepatitis B (CHB). The Fast Track designation aims to expedite the development … Read the full press release