Latest Content

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.

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.