Merck's BLA for RSV Antibody Clesrovimab Gets FDA Acceptance

Merck (MRK) announced that the FDA has accepted the biologics license application (BLA) for its investigational prophylactic long-acting monoclonal antibody, clesrovimab (MK-1654), designed to protect infants from respiratory syncytial virus (RSV) disease entering their first RSV season.With the FDA accepting the BLA for review, a decision from the regulatory body is expected on June 10, 2025.Clesrovimab is likely to be available by July 2025 in the United States.If approved, clesrovimab can help address th ...