A Prescription Drug User Fee Act target date of December 12, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the Biologics License Application ...

LIB Therapeutics announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lerodalcibep, a treatment aimed at lowering low-density ...

A mong patients at high or very high risk for a heart attack or stroke, the addition of the investigational drug lerodalcibep to standard cholesterol-lowering medication for one year reduced LDL ...

Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor, with long-ambient stability, developed as a more patient-friendly, once-monthly, self-administered ...