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How organizations can gain an edge in the enterprise transformation to unified analytics that's accelerating across pharma.

Industry experts across the biotech sector discuss the latest trends impacting emerging biotech companies, including the challenges of early-stage biotech start-ups, AI integration across the sector, and the most recent innovations in drug discovery.

Testing reveals that compounded tirzepatide products mixed with vitamin B12 contain a chemical impurity of unknown toxicity.

Vincent Hennemand discusses using these types of therapies to develop treatments for autoimmune conditions.

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter stemming from a 2025 inspection of its U.S. headquarters, and Pharmaceutical Executive's latest analysis examines the state of the biopharma industry as it navigates a period of cautious momentum.

Fresh off 2025, where the sectors delivered strong stock gains and selective financing momentum despite volatile markets, companies navigate policy headwinds, patent cliffs, and shifting global innovation dynamics, factors that favor strategically driven growth pursuits ahead.

FDA cites systemic failures in how the company tracked and reported adverse drug events across several of its medicines, including semaglutide.

Leaning into a future downward pricing environment in pharma.

FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, pricing uncertainty and safeguards.

Europe’s Joint Clinical Assessment promises harmonization, but it introduces a new layer of strategic complexity that manufacturers must navigate at both EU and national levels.

Ron Wyden led 7 Democrats demanding details from Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly.

In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA Priority Review for HER2-positive early breast cancer in the post-neoadjuvant setting, and a new commentary argues that AI has fundamentally changed how healthcare communicators must think about content strategy.