Operations

The agency also named a new head of its Office of Nonprescription Drugs.

The former FDA oncology chief is set to resign by the end of the month.

The agency says that the decision aims to improve employee workflow and build on its previously implemented generative AI tool Elsa.

Q&A with Krishna Kanumuri, CEO of Sai Life Sciences, on steering a contract development and management organization through growth, scale-up, and the shifting global supply chain in pharma.

Novartis is planing layoffs in Switzerland, along with plans to invest $80 million to enhance RNA treatment production and create new jobs by 2028.

Pharmaceutical collaborations expand as Flagship Pioneering expands its partnership with GSK, signing agreements with ProFound Therapeutics and Quotient Therapeutics, while Valo Health teams up with Merck KGaA to tackle disease challenges.

Abbott's acquisition of Exact Sciences enhances cancer diagnostics and expands access to innovative screening and treatment solutions for patients worldwide.

Johnson & Johnson aims to enhance its oncology portfolio and innovate prostate cancer treatments by expanding its therapeutic pipeline through the acquisition.

UnitedHealth Group appoints Dr. Scott Gottlieb to its board, enhancing leadership amongst a time in which the company looks to enhance its public outlook.

Eli Lilly invests $3 billion in a new European manufacturing facility, enhancing production capacity and creating jobs while ensuring faster access to innovative medicines.

Organon faces leadership changes as CEO Kevin Ali resigns amid an investigation into improper sales practices involving Nexplanon.

The decision impacts hopes for preventing congenital infections, although the company is continuing other research initiatives.

Clinical trial sites face persistent payment delays and complex processes, risking their viability and impacting drug development. Solutions prioritize transparency and flexibility.

Cencora CEO Bob Mauch discusses the lessons learned during his first year at the helm—and tackling a complex future for pharma distribution.

Merck invests $70 billion in US operations, launching a $3 billion manufacturing site in Virginia to enhance drug production and create jobs.

Johnson & Johnson plans to separate its orthopaedics business, creating DePuy Synthes, to enhance focus, innovation, and value for stakeholders.

Ypsomed invests $250 million in a new U.S. manufacturing facility, enhancing local supply and creating jobs in Holly Springs, North Carolina.

The key steps for pharma in pivoting from proof-of-concept experimenting to enterprise-scale value.

With healthcare at a key crossroads of policy, technology, and science, Sanofi CEO Paul Hudson shares the Big Pharma’s formula for navigating the new age of innovation, where running from risk is not an option.

Ken Banta, founder and CEO of The Vanguard Network, reveals the mindsets and moves biopharma leaders need to not just endure—but rise above—the current age of industry disruption.

The company is downsizing its gene therapy operations following reduced demand from a major client, even as industry reliance on CDMOs and CMOs for capacity and expertise continues to grow.

An examination of proactive preparedness and readiness review for future enrollment in the agency’s QMM program—now in the pilot stage as an effort to incentivize pharma manufacturers to achieve a more mature state of quality culture.

Despite steady innovation and solid new drug approvals, the first half of 2025 was marked by a break from historical norms in financing, stock performance, and M&A for the pharma and biotech sectors.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

A well-defined scientific and strategic approach is critical for buyers in this dealmaking setting.