
Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions, discusses FDA's shift to a single pivotal trial standard, in an effort to streamline drug development without lowering the scientific bar.

Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions, discusses FDA's shift to a single pivotal trial standard, in an effort to streamline drug development without lowering the scientific bar.

In today's Pharmaceutical Executive Daily, a new West Health-Gallup survey finds that more than 82 million Americans have cut back on daily expenses to cover healthcare costs, the FDA expands the approved age indication for GSK's RSV vaccine Arexvy to adults aged 18 to 49 at increased risk, and a new commentary argues that agentic AI is positioned to fundamentally reshape commercial operations in life sciences.

Inside Consano Bio’s bet on first-in-class nerve repair—and what it takes to lead an early-stage biotech through uncertainty.

Aravo CCO Dave Rusher discusses the risk of third-party AI usage at pharma companies.

A nationally representative survey of more than 20,000 U.S. adults found that 33% made at least one daily spending trade-off to pay for healthcare in the past year

Arexvy is now approved for adults aged 18 to 49 with underlying conditions that elevate their risk of severe RSV disease.

In today's Pharmaceutical Executive Daily, Senate Democrats press major pharmaceutical companies for transparency on the terms of their most-favored-nation pricing deals with the Trump administration, a new analysis examines the gap between the promise and the reality of Europe's Joint Clinical Assessment framework, and Eli Lilly issues a public safety warning about compounded tirzepatide products mixed with vitamin B12.

How organizations can gain an edge in the enterprise transformation to unified analytics that's accelerating across pharma.

Industry experts across the biotech sector discuss the latest trends impacting emerging biotech companies, including the challenges of early-stage biotech start-ups, AI integration across the sector, and the most recent innovations in drug discovery.

Testing reveals that compounded tirzepatide products mixed with vitamin B12 contain a chemical impurity of unknown toxicity.

Vincent Hennemand discusses using these types of therapies to develop treatments for autoimmune conditions.

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter stemming from a 2025 inspection of its U.S. headquarters, and Pharmaceutical Executive's latest analysis examines the state of the biopharma industry as it navigates a period of cautious momentum.

Fresh off 2025, where the sectors delivered strong stock gains and selective financing momentum despite volatile markets, companies navigate policy headwinds, patent cliffs, and shifting global innovation dynamics, factors that favor strategically driven growth pursuits ahead.

FDA cites systemic failures in how the company tracked and reported adverse drug events across several of its medicines, including semaglutide.

Leaning into a future downward pricing environment in pharma.

FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

ICON Biotech surveyed 163 biotech leaders in North America, EMEA and APAC to see how they are responding to the headwinds.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, pricing uncertainty and safeguards.

Europe’s Joint Clinical Assessment promises harmonization, but it introduces a new layer of strategic complexity that manufacturers must navigate at both EU and national levels.

Ron Wyden led 7 Democrats demanding details from Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly.

In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA Priority Review for HER2-positive early breast cancer in the post-neoadjuvant setting, and a new commentary argues that AI has fundamentally changed how healthcare communicators must think about content strategy.

FDA approved GSK's Wellcovorin as the first treatment for cerebral folate deficiency caused by a rare genetic variant.

The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to consolidate into a single robust pivotal study.

Conversational AI is pushing engagers to prioritize clear, explainable guidance as patients and clinicians delegate understanding to chatbots.

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the second time in under a year, major deal activity including a GSK and Alfasigma licensing agreement along with Servier’s $2 billion acquisition of Day One Pharmaceuticals, and Ipsen withdraws Tazverik from the market following emerging clinical trial data.

The deal comes after Novo took legal action against Hims to prevent the company from offering compounded GLP-1 medications.

Ipsen is withdrawing its EZH2 inhibitor Tazverik from all markets after an ongoing clinical trial identified safety concerns involving secondary blood cancers.

The vaccine chief briefly left the role last summer before almost immediately returning to it.

The GSK licensing deal is reportedly worth up to $690 million.