FDA priority review of Jemperli for biomarker-defined rectal cancer signals capacity, supply chain, and global filing shifts ...

McKesson plans to absorb Precision Medicine Group into Oncology & Multispecialty, adding CRO, lab, biomarker, market access, and commercialization capabilities to its existing healthcare services ...

Marco Anelli, MD | Authors | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

FDA imposed a clinical hold on RGX-121 after spine MRI surveillance detected asymptomatic spinal nodules/cystic masses in five participants dosed intracisternally or intraventricularly 3–6 years prior ...

Schmitt and Schniepp stress that merely citing a standard (e.g., "we followed GAMP") doesn't guarantee compliance. According ...

David S. Thompson, CSAP, is Chief Alliance Officer at Eli Lilly and Company.

Chris Williams serves as executive director, Analytical Development ILM at Alcami, bringing more than a decade of experience ...

On August 19,2026, the FDA accepted Teva Pharmaceuticals' New Drug Application (NDA) for ecopipam, an investigational ...

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control, and FDA data trust, the key shifts pharma professionals must track.

Pharma industry experts indicate that strategy in 2026 is shifting to agentic AI, sustainable efficiency, and resilient supply chains to manage tariffs, regulations, and digitalization. To formulate a ...

Accelerated approval relies on cornstarch-reduction as a surrogate endpoint, with crossover follow-up planned at 96 and 144 weeks to further characterize durability and clinical benefit.

For peptide programs, then, nitrosamine strategy is likely to succeed only when it is embedded inside broader analytical ...