FDA expands Dupixent approval to children aged 2–11 with chronic spontaneous urticaria, marking the first biologic option for this population and extending its reach across type 2 inflammatory diseases.
AbbVie has announced a $1.4 billion investment to build a new pharmaceutical manufacturing campus in North Carolina, expanding its U.S. footprint with a focus on advanced sterile injectable production.
MaxCyte CEO Maher Masoud discusses how new treatment methods are providing greater control of the therapy’s safety profile.
In today’s Pharmaceutical Executive Daily, the FDA approves a new treatment for HIV-1 infection in adults, Amazon One Medical launches a GLP-1 weight management program, and a new report highlights which top-selling drugs are most at risk of supply shortages.
FDA has approved Merck’s Idvynso, introducing a differentiated, two-drug, non-INSTI, tenofovir-free HIV regimen that maintains viral suppression while offering a potentially more tolerable, simplified option for long-term patient management.
Amazon has launched a new GLP-1 weight management program through its One Medical network, integrating obesity treatment into primary care while expanding access to both telehealth services and a range of branded medications.
Enabling highly individualized treatment approaches that align with each patient’s unique physiology, goals, and tolerability, compounding can have a significant impact.
Supply chain chokepoints are converging to expose deep structural vulnerabilities in the U.S. drug supply, with new data showing that even medicines not currently in shortage may be one disruption away from crisis.
In today’s Pharmaceutical Executive Daily, UnitedHealth raises its full-year profit forecast following stronger-than-expected first-quarter results, Pfizer works to reshape its leadership narrative as it approaches a major patent cliff, and a new industry perspective highlights why scaling artificial intelligence in pharma requires more than just advanced algorithms.
Organizations must build a strong foundation that anchors AI deployments in critical areas.
Maher Masoud, CEO of MaxCyte, discusses the need for developers to come together with platforms.
UnitedHealth Group reported stronger-than-expected first-quarter earnings and raised its full-year outlook, signaling improving cost control and early progress in stabilizing performance.
Pfizer’s broad pipeline and recent acquisitions have yet to translate into a coherent market narrative, contributing to investor uncertainty during a critical period of strategic transition.
In today’s Pharmaceutical Executive Daily, Eli Lilly enters a $7 billion agreement to acquire Kelonia Therapeutics, the Trump administration issues an executive order to accelerate FDA reviews of psychedelic therapies, and Lilly’s oral weight loss pill sees strong early prescribing demand.
The Trump administration’s new executive order aims to accelerate FDA review of psychedelic therapies for mental health conditions, highlighting a potential shift in regulatory timelines and expanded access pathways,
Eli Lilly’s acquisition of Kelonia Therapeutics signals a potential shift in the cell therapy landscape, as in vivo approaches aim to overcome the cost, complexity, and access limitations of traditional CAR-T treatments.
Samsung Bioepis’ SVP and head of US commercial discusses the pricing, regulatory, and broader issues impacting the biosimilars market.
Model N’s Michael Grosberg breaks down the accelerated complexity, policy disruption, and data gaps testing manufacturer market access and revenue management strategies.
Market analysts are comparing Foundayo’s sales with other GLP-1 medications, such as the oral version of Wegovy.
The President also announced a number of other key leadership appointments at federal health agencies.
Morten Graugaard, CEO, Orbis Medicines, discusses the importance of oral biologics and the industry impacts of FDA's approval of Icotyde.
ARS Pharmaceutical’s CEO discusses how reformulating drugs and updating delivery design can improve the rate of patient adherence to medication.
Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses how the Tecvayli and Darzalex Faspro combination delivers deep, durable responses, along with its rapid FDA review.
In today's Pharmaceutical Executive Daily, Eli Lilly releases updated safety data for its oral obesity pill Foundayo in response to an FDA post-approval request, ICER and Verdant Research publish a new white paper examining the evolution and future of the FDA's accelerated approval pathway, and a new Pharmaceutical Executive commentary argues FDA's shift toward single-trial approval standards marks the beginning of a genuinely new era in data-driven drug development.
A new ICER white paper calls for reforms to the FDA’s accelerated approval pathway, citing ongoing challenges with regulatory consistency, confirmatory trial delays, and transparency.
Eli Lilly releases new safety data after FDA requested additional data to conduct extensive post-approval safety studies for Foundayo, including long-term monitoring of cardiovascular, liver, and thyroid cancer risks.
Samsung Bioepis’ Thomas Newcomer explains the reasons why biosimilar developers are or are not feeling confident about the consistency of the US market in the coming years.
Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses why J&J was chose for the CNPV program and it's experience during the process.
Elevating real-world data (RWD) to the status of regulatory-grade evidence will bring both opportunity and challenges to the industry.
Recent breakthroughs in artificial intelligence allow specialized language models to automatically extract critical information from thousands of complex drug labels in minutes instead of days.
