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.
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?
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.
In today’s Pharmaceutical Executive Daily, new analysis outlines how EMA support programs help lower drug market entry costs, early real-world data show sustained remissions with Carvykti in relapsed or refractory multiple myeloma, and Pfizer signs an exclusive collaboration with Yao Pharma to advance oral small-molecule GLP-1 agonists.
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.
Carvykti’s emerging Phase III data shows that a single early-line infusion can deliver durable, treatment-free remissions lasting beyond 30 months for patients with relapsed or refractory multiple myeloma.
Evaluating standard clinical focus through the growing financial lens.
Jaypirca matched response rates for Imbruvica with potentially improved survival in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma.
Welcome to Pharm Exec's new guest column on navigating the geopolitical risks challenging core company strategies in today's shifting global landscape for healthcare.
Gillian Woollett, VP and head of regulatory strategy at Samsung Bioepis, discusses how the current regulatory climate is the result of years of work.
