Sept. 30 marked 61 days since July 31, one day past the timeframe President Donald Trump had set forth for companies to lower prescription drug prices in the United States.

EMA's draft reflection paper promotes using patient experience data in drug regulation to enhance decision-making processes. Patient perspectives, such as quality of life, complement scientific data ...

In this continuation of a three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

FDA's Center for Biologics Evaluation and Research has released updated draft recommendations for sponsors of cell therapies, gene therapies, and tissue products.

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

Alvin Jogasuria, ProBio; Matthew Lunning, University of Nebraska Medical Center; and Carl Schoellhammer, DeciBio, go behind ...

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, ...

“Integrating PAT enables right-first-time production, as real-time data and predictive models minimize errors and ensure ...

EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.

The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal ...

Agentic AI enables autonomous coordination of AI agents, offering potential for process reinvention in life sciences beyond ...

The week's pharma news includes FDA warnings for Lilly and Novo, new drug approvals for MASH and edema, and a look ahead at ...