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Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.

A fragmented approach to drug discovery created structural inefficiencies that drive up R&D costs.

In today’s Pharmaceutical Executive Daily, Eli Lilly announces three acquisitions totaling roughly $3 billion, the FDA approves Hepcludex as the first treatment for chronic hepatitis delta virus infection in the United States, and biotech finance leaders reflect on the lessons learned from navigating two decades of volatile markets.

FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major milestone for a severe liver disease with limited therapeutic options.

Eli Lilly enters three separate acquisitions totaling $3.83 billion in a push into vaccines and infectious diseases, signaling a strategic expansion into prevention-focused medicines.

Harpreet Singh, MD, touches on how the Commissioner’s National Priority Voucher program is accelerating regulatory review timelines without fundamentally changing how pivotal trials are designed.

The Deloitte Consulting partner discusses how GLP-1s are becoming key value drivers and driving R&D focus during a period of market concentration.

Drawing on nearly two decades in biotech finance,Troy Ignelzi outlines why operational discipline, strategic storytelling, and long-term conviction have become essential survival tools in an increasingly unforgiving life sciences market.

Reputation is one of the factors that influences whether the people who matter most to your business decide whether to move with you.

In today’s Pharmaceutical Executive Daily, the FDA approves Datroway for certain patients with metastatic triple-negative breast cancer, leadership changes continue at the National Institutes of Health with the departure of a top infectious disease institute director, and industry experts discuss how real-time data is reshaping biotech decision-making and development strategy.

FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer, expanding treatment options for patients ineligible for PD-1/PD-L1 inhibitor therapy.

Jeffrey Taubenberger’s departure was announced by Senator Baldwin during a congressional hearing.