FDA Watch: Key Decisions for Merck, Verona, AbbVie, Rocket


The U.S. Food and Drug Administration (FDA) is gearing up for a crucial week as it prepares to make decisions on four significant target action dates. Among the applications under review are a label expansion for Roche’s bispecific antibody, Lunsumio, and Rocket Pharmaceuticals’ investigational gene therapy for a rare pediatric heart condition, Danon disease.

Merck is also awaiting the FDA’s verdict on a new drug application for MK-2060, an oral PCSK9 inhibitor for the treatment of adults with hypercholesterolemia. Additionally, the agency is set to announce its decision on Verona Pharma’s ensifentrine, a novel dual inhibitor of phosphodiesterase 3 and 4, as a potential treatment for chronic obstructive pulmonary disease (COPD).

The biotech and pharmaceutical industry is closely monitoring these FDA actions, as they could significantly impact the treatment landscape for various conditions. The outcomes of these regulatory decisions will be eagerly anticipated by healthcare professionals, patients, and investors alike.