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Brent Saunders: Eyeing New Horizons

FDA Approves Amgen's Uplizna for Generalized Myasthenia Gravis With Positive AChR or MuSK Antibodies

The GLP-1 Gold Rush

TrumpRX Has a Blind Spot and It Can Redefine Patient Access

How Are Global Regulatory Agencies Adjusting Their Policies for Biosimilars?

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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.

Lilly’s first Phase III results for retatrutide show unprecedented weight loss and marked reductions in osteoarthritis pain, underscoring the potential of its triple-agonist therapy to reshape treatment for obesity and related metabolic conditions.

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

OTR Therapeutics Announces Collaboration with Zealand Pharma to Develop Metabolic Disease Treatments
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.

Waskyra’s FDA approval marks a milestone for rare disease care and for Fondazione Telethon, establishing the first nonprofit-led ex vivo gene therapy to reach market after decades of research.

With prescription care changing, it’s up to benefits providers to reinforce the value of human connection in a complex system.

In today’s Pharmaceutical Executive Daily, the FDA introduces a new superiority standard for future CAR-T approvals, Relation Therapeutics and Novartis form a $1 billion multi-program collaboration targeting atopic diseases, and new insights reveal how payers are shaping expectations for Phase III trial design.

FDA’s approval of Augmentin XR as the first therapy cleared under the new National Priority Voucher Pilot Program signals a decisive push to strengthen domestic antibiotic manufacturing, accelerate critical drug reviews, and stabilize long-strained U.S. antimicrobial supply chains.

How pharma marketers can time brand messages to prescribers when it matters most.



















