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FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

ICON Biotech surveyed 163 biotech leaders in North America, EMEA and APAC to see how they are responding to the headwinds.

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.

The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to consolidate into a single robust pivotal study.

Conversational AI is pushing engagers to prioritize clear, explainable guidance as patients and clinicians delegate understanding to chatbots.

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the second time in under a year, major deal activity including a GSK and Alfasigma licensing agreement along with Servier’s $2 billion acquisition of Day One Pharmaceuticals, and Ipsen withdraws Tazverik from the market following emerging clinical trial data.