May 10th 2024
Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.
Results of Phase III Trial Show Promise of Potential First-in-Class Treatment for Dry Eye Disease
February 28th 2024PL9643 ophthalmic solution is a melanocortin agonist with a novel mechanism of action that produced a clinically meaningful and statistically significant reduction in pain associated with dry eye disease.
Phase III Trial Data for Scemblix Show Clinically Meaningful Response in Chronic Myeloid Leukemia
January 8th 2024Phase III ASC4FIRST show Scemblix (asciminib) plus investigators’ choice of tyrosine kinase inhibitor produced a statistically significant response in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Sharon Hesterlee of the Muscular Dystrophy Association Speaks on New Therapy, Vamorolone
December 18th 2023In an interview with ACT editor, Andy Studna, Hesterlee, Chief Research Officer at the Muscular Dystrophy Association discusses a new therapy for Duchenne Muscular Dystrophy, Vamorolone, and what sets it apart from other therapies in the market.