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The FDA’s approval of Uplizna for antibody-positive generalized myasthenia gravis introduces a twice-yearly CD19-targeted therapy option for the rare autoimmune condition.

Ascension of agonist class touching all parts of the market—from science to strategy.

TrumpRx’s promised drug-price cuts expose a deeper systemic flaw, positioning direct-to-patient clinical pathways as the infrastructure pharma must build to turn political headlines into real access and outcomes.

In the third and final part of her conversation with Pharmaceutical Executive, discusses the ways that regulatory agencies in major global markets are acting in similar ways to have a positive impact on the biosimilars market.

Experts weigh in on FDA’s new accelerated review program, revealing what companies stand to benefit the most from the initiative.

With patent cliffs fast approaching, asset differentiation will be king.

Amid the US reshoring push, drugmakers navigate geopolitical and supply chain risks.

In today’s Pharmaceutical Executive Daily, new analysis outlines what it may truly cost to fix the biopharma ecosystem, the FDA approves Waskyra for patients with Wiskott-Aldrich syndrome, and OTR Therapeutics enters a strategic collaboration with Zealand to develop novel metabolic disease therapies.

Why the new wave of direct-to-consumer access represents more than a passing trend.

Will the politically fueled reforms and mandates around drug pricing reduce the complexity of the system?

The deal will provide Zealand with access to OTR’s proprietary R&D platform.

In the second part of her conversation with Pharmaceutical Executive, Gillian Woollett, VP and head of regulatory strategy at Samsung Bioepis, explains the direct impact changes at FDA have on the biosimilar space.

Outlining the big questions and considerations for pharma companies in determining their readiness for this transformation—and achieving true “AI Advanced” status.