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.
Alvin Jogasuria, ProBio; Matthew Lunning, University of Nebraska Medical Center; and Carl Schoellhammer, DeciBio, go behind ...
“Integrating PAT enables right-first-time production, as real-time data and predictive models minimize errors and ensure ...
The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant ...
The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal ...
The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products ...
EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.
Misleading promotions of GLP-1 and compounded semaglutide products are drawing renewed regulatory scrutiny over risk ...
Agentic AI enables autonomous coordination of AI agents, offering potential for process reinvention in life sciences beyond ...
David McErlane, Group President of Biologics at Catalent, shares how integrated expertise in biologics helps simplify ...
The week's pharma news includes FDA warnings for Lilly and Novo, new drug approvals for MASH and edema, and a look ahead at ...
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