FDA's review of filing for osteoporosis abaloparatide delayed by three months to June 30, bringing it closer to the action date for Amgen's competing anabolic agent romosuzumab, which has an action date of July 19.
Radius Health Inc. announced that FDA has extended the user fee date for its anabolic osteoporosis drug abaloparatide from March 30 to June 30, soon after the company discussed extensive plans for launch with no mention of a regulatory delay.
FDA needs more time to review the NDA for the daily subcutaneous formulation in postmenopausal osteoporosis "to allow time to review information submitted by Radius Health in response to the FDA's
Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.
Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.
In this week's episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.
