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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.

New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while simultaneously easing REMS requirements to reduce logistical burdens for treatment centers and patients.

Relation Therapeutics and Novartis launch a multi-program alliance combining Relation’s AI-powered, patient-derived discovery engine with Novartis’s immuno-dermatology capabilities.

Pfizer’s exclusive partnership with Yao Pharma secures global rights to the oral GLP-1 agonist YP05002, advancing its cardiometabolic pipeline.

In today’s Pharmaceutical Executive Daily, the FDA greenlights an expanded use of Breyanzi, Eli Lilly reports Jaypirca met its primary endpoint in a head-to-head Phase III trial against Imbruvica for CLL/SLL, and new analyses highlight how health systems are strengthening partnerships to support cell and gene therapy commercialization.

The European pharmaceutical market, representing 20% of the global pharmaceutical market, is not a fortress to be feared but an opportunity to be seized.