SPL84 therapy on FDA fast track for CF due to splicing mutation

The U.S. Food and Drug Administration (FDA) has granted fast track designation to SPL84, an experimental inhalation therapy for people with cystic fibrosis (CF) caused by the 3849+10 kb C-to-T mutation in the CFTR gene. The designation is given to accelerate the development and review of therapies meant to address unmet…

BX004 on fast track to treat P. aeruginosa infections

The U.S. Food and Drug Administration (FDA) has granted fast track designation to BX004, a virus-based therapy that BiomX is developing to treat Pseudomonas aeruginosa bacterial infections in people with cystic fibrosis (CF). The FDA gives this designation to therapies that are designed to address unmet medical…

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