Astellas CEO Naoki Okamura is putting a “patient axis” operating model, a broader portfolio of strategic brands and a new generation of science to work in the company’s bid to return to record growth.

As established gains in personalized and targeted therapy have enabled increasingly precise approaches to disease, novel technologies are expanding what is possible while creating new challenges for drug developers.

A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.

AI does not end uncertainty in pharma strategy. Its value depends on how well leaders blend it with experience and evidence while keeping judgment human.

FDA is launching the Rare Disease Framework Initiative, aiming to tailor drug development and review requirements to the realities of small patient populations.

ESC 2026 marked a turning point — GLP-1s earn their first formal heart failure guideline recommendation and become a cardiometabolic platform.

Fox Rothschild's Marc Wagner on why domestic manufacturing reduces drug shortage risk — and why FDA inspection efficiency is as important as supply chain resilience.

MERGE's Pat McGloin on why pharma AI fails when strategy follows technology — and why the brilliant basics still have to come first.