By IDSE News Staff
The FDA accepted the biologics license application (BLA) for clesrovimab (MK-1654), Merck’s investigational, prophylactic, long-acting monoclonal antibody (mAb) designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.
The agency set a Prescription Drug User Fee Act (PDUFA) date of June 10, 2025.
The application is supported by results from the pivotal phase 2b/3 CLEVER trial (MK-1654-004), a randomized,