May 2026

Biotech Pharmaceutical Regulation

Brief summary of safety pharmacology studies

The assessment of safety pharmacology is primarily governed by the ICH S7A (Core Battery) and ICH S7B (Cardiovascular) guidelines. These studies are designed to investigate potential undesirable pharmacodynamic effects on vital functions before human exposure. Here is the comprehensive list...

Molecule Digest Pharmaceutical Sci&Tech

The Nonclinical Studies Lead to the First FDA Approved PROTAC-Veppanu

As a PROTAC (Proteolysis-Targeting Chimera), vepdegestrant represents a novel class of heterobifunctional degraders, and its non-clinical package focused heavily on its unique mechanism and potential for off-target effects. Based on the FDA approval documentation for VEPPANU...

Pharmaceutical Regulation Sci&Tech

VEPPANU A Breakthrough of PROTAC

The drug ARV-471, now known by its generic name vepdegestrant and brand name VEPPANU, has made history. As of May 1, 2026, it became the first-ever PROTAC (Proteolysis-Targeting Chimera) to receive FDA approval. Discovered through the pioneering work at Arvinas and detailed in...