US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape ...

FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza ...

Transaction diligence increasingly stress-tests supply chain integrity across the full patient journey for cell and gene ...

A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...

In biologics development, there is a constant tension between moving quickly and making the right decisions early. As programs progress toward the clinic, early cell line development plays a central ...

As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...

Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the ...

FDA’s durable expectation is that AI outputs can aid drafting, but must be reviewed and cleared by an authorized QU ...

Oncology remains the leading M&A magnet, with ASCO data catalyzing interest in new combinations and next-generation ...

Eli Lilly was attracted by a deliberately cultivated life sciences strategy anchored in a region where manufacturing ...

Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems. Rare medical conditions can do more than ...